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PURPOSE To investigate the incidence of deepening of the upper eyelid sulcus (DUES) with topical use of travoprost in Japanese glaucoma patients. PATIENTS AND METHODS This prospective study enrolled 32 primary open-angle glaucoma Japanese patients who had been treated topically with travoprost unilaterally for 6 months at baseline, and started treatment in both eyes. The patients were observed during outpatient visits at 2, 4, and 6 months. At every visit, the photographs of both eyes and forehead were displayed randomly and the presence of DUES was diagnosed when 3 examiners unanimously rated the case as positive. The patients were also asked if they noticed any subjective symptom of DUES. Sex, refraction, and intraocular pressure (IOP) were evaluated as potential risk factors. RESULTS DUES was identified objectively in 34% (11/32) of the patients after 2 months of treatment, and in 53% (17/32) after 4 and 6 months of treatment. The incidence was significantly higher in older patients (P

Purpose To determine if adherence and convenience of once-daily glaucoma medication is greater in the morning or the evening. Design Prospective, randomized crossover treatment trial. Patients and methods Thirty patients newly diagnosed with glaucoma or ocular hypertension requiring intraocular pressure (IOP) reduction were started on travoprost eye drops and randomized to either morning or evening administration for 1 month. They were then crossed over to the opposite dosing schedule for the following month. Adherence was monitored using an automated dosing aid. Main outcome measures Adherence was compared between morning versus evening dosing and first versus second month dosing. Demographic characteristics were obtained, treatment effect was measured, and patients completed a post-study questionnaire regarding the convenience of the 2 dosing regimens. Results Patient adherence overall was good (89.3%). There was no statistically significant difference (P=0.07) in adherence between morning dosing (90.9%) and evening dosing (87.3%). Adherence in the first month (91.7%) was superior to the second month (86.5%). There was no significant difference in IOP response between morning and evening dosing. Patients found morning dosing more convenient than evening dosing. Conclusions Early adherence to treatment with a prostaglandin analogue is good, but patients prefer morning administration to evening administration. This may lead to greater adherence with morning administration, particularly among men. Adherence decreases from the first to second month after initiation of treatment. IOP response to this treatment is not significantly affected by morning versus evening administration.

To compare the efficacy of brinzolamide versus placebo when added to travoprost/timolol fixed combination (TTFC) in uncontrolled patients.This was a prospective, double-masked, randomized, placebo-controlled, parallel comparison of ocular hypertensive or primary open-angle glaucoma patients. Patients treated with a prostaglandin-based mono or adjunctive therapy were changed to TTFC qam (every day dosing) for 4 weeks. Patients with an intraocular pressure (IOP) of 19 to 32 mm Hg at 08:00 hours underwent additional measurements at 12:00 and 16:00 hours. Patients were then randomized to either placebo or brinzolamide given twice daily in addition to TTFC. At week 12, patients had their IOP measurements repeated.The per protocol dataset consisting of 78 placebo and 75 brinzolamide-treated patients decreased mean diurnal IOP (mm Hg) as well as IOP at all 3 individual time points (P≤0.005). Brinzolamide reduced the mean diurnal IOP from 20.3±2.0 to 17.5±2.6, whereas placebo reduced IOP from 20.9±2.7 to 19.4±3.8. The mean diurnal IOP was reduced from baseline and for the 08:00 and 16:00 hours time points in the brinzolamide group compared with placebo (P≤0.014). There were 30 adverse events with placebo and 24 with brinzolamide (intent-to-treat). There was no statistical difference for the side-effect profile observed between the treatment groups (P=0.47).This study suggests that brinzolamide may be safely added to TTFC therapy to provide further significant reduction in IOP patients with ocular hypertensive or primary open-angle glaucoma.

OBJECTIVE To examine the intraocular pressure-lowering efficacy and safety of travoprost 0.004% and pilocarpine 1% in Chinese patients with primary angle-closure (PAC) and primary angle-closure glaucoma (PACG) after laser iridotomy in China. PATIENTS AND METHODS Thirty patients with PAC or PACG after laser iridotomy were randomized into this double-masked, parallel-group study. Qualified patients had a mean intraocular pressure (IOP) between 21 and 35 mm Hg; inclusive at 9 AM at eligibility visit and previously undergone laser peripheral iridotomy at least 30 days before screening visit. Patients were treated with travoprost 0.004% once daily or pilocarpine 1% 4 times daily for 12 weeks after appropriate washout of glaucoma medications. Efficacy and safety evaluations were conducted at weeks 4, 8, and 12. IOP measurements were performed at 9 AM and 4 PM at baseline and week 12 visits, except at the weeks 4 and 8, when the IOP measurement was undertaken respectively at 9 AM or 4 PM only. The degree and distribution of peripheral anterior synechiae was evaluated by gonioscopy at baseline and week 12, respectively. RESULTS Both the treatment groups showed statistically significant IOP reductions from baseline, except for the results of pilocarpine group at 4 PM in week 12. Travoprost demonstrated a statistically superior IOP reduction (7.6 mm Hg) compared with pilocarpine (1.9 mm Hg; P=0.04) at 4 PM over the 12-week period. There was no difference in peripheral anterior synechiae degree and distribution in week 12 from baseline for both treatment groups. No serious adverse event was found in both the groups. CONCLUSIONS Travoprost 0.004% once daily provides effective IOP-lowering efficacy with significantly greater IOP reduction from baseline when compared with pilocarpine 1% 4 times daily at 4 PM over the 12-week period. Travoprost 0.004% once daily is safe and well tolerated in PAC or PACG patients.

Latanoprost, travoprost, and bimatoprost are prostaglandin or prostamide-type ocular hypotensive medications, all of which are effective and safe for lowering intraocular pressure (IOP). Most studies with these types of drugs have included patients mainly from European or white ethnic backgrounds; however, some reports have suggested that there is a difference in response between patients of white and African racial heritage. On account of the possibility that drugs may act differently in people of different ethnic background, we decided to study the effectiveness and safety of all 3 drugs in people from various ethnic heritages. Our hypothesis was that there might be a possible ethnic-based difference in IOP-lowering effectiveness between the 3 medications.This was a prospective randomized investigator-masked multicenter study. Patients newly diagnosed with open-angle glaucoma (primary, pseudoexfoliative, or pigmentary), or whose pressure became elevated after a washout period, were randomized to receive 1 of 3 prostaglandin/prostamide drugs. Assignment of drug was balanced by racial group and study site, and the investigator was masked to the drug used. The patients were requested to self-identify their racial group as White, African, East Indian, Asian, or Hispanic; to minimize the possibility of heterogeneity, all 4 grandparents had to be known to originate from the same group. However, for purposes of analysis, the patients were divided into 2 groups--White or Other. Patients were followed at 2, 6, 12, and 24 weeks; IOP and local side effects were assessed at each visit.Eighty-three patients were recruited from 9 sites. The mean age of the patients was 61.5 ± 10.5 years. There were no differences in mean age or the distribution of sex between the patients whether examined by the 2 racial groups or the 3 drug groups. There was a highly statistically significant decrease in IOP from baseline to 12 weeks and from baseline to 24 weeks (F = 439.3, P0.0001; F = 305.94, P0.0001). There were no differences in treatment effect between the 3 drugs or between the 2 ethnic groups, (P0.05 for all comparisons) and there was no interaction between race and drug.All 3 prostaglandin/amide drugs are highly effective at lowering IOP. No differences in effect between the drugs or between members of different racial groups were detected, although the study sample size was too small to be certain to detect differences, if they existed.

PURPOSE To assess the efficacy and safety of switching patients from bilateral latanoprost to bimatoprost in 1 eye while maintaining latanoprost in the fellow eye. PATIENTS AND METHODS This prospective, open-label, multicenter, uniocular (within-eye control) study was conducted from March 2005 to February 2007; 105 patients with glaucoma or ocular hypertension were enrolled. At baseline, patients using bilateral latanoprost were switched to bimatoprost treatment in 1 eye (study eye) and continued latanoprost treatment in the fellow eye (control eye). At 12 weeks, patients were offered bilateral bimatoprost for 12 additional weeks. RESULTS At week 12, the mean difference in intraocular pressure (IOP) from baseline was -3.0 mm Hg in study eyes and -1.6 mm Hg in control eyes, which equates to a further -1.4 mm Hg (95% confidence limits: -1.9, -0.9) reduction in IOP in study eyes compared with control eyes (P or = -2.5 mm Hg reduction in IOP than control eyes (P

Purpose To investigate the topical use of travoprost [Trademark: Travatan (Alcon laboratories Inc, TX)] and the incidence of iridial pigmentation change in the brown irises of Chinese eyes. Materials and Methods Design: Prospective, masked, observational study. Enrolled in the study were 37 Chinese subjects (73 eyes) with primary open-angle glaucoma who were being treated for the first time with travoprost eye drops (patient-group). Twenty-one Chinese volunteers with normal eyes (42 eyes) served as the control-group. To evaluate iris pigmentation, photographs were taken of the control-group's irises using a slit-lamp biomicroscope with attached digital camera. Before the start of travoprost treatment and 3 months after the start of travoprost treatment, photographs of the irises of the patient-group were taken using the same photographic methods. Five glaucoma specialists independently read the series of photographs to determine if there was an increase in iris pigmentation. Three of the 5 observers had to be in agreement that there was an increase from the baseline. “Picture Color Analyzer” computer software was also used to calculate the color value of each iris picture. Results Observation with eyes: Twenty-six eyes (35.6%) in the patient-group developed an increase in iris pigmentation compared with zero subjects (0%) in the control-group (P=0.000, χ2 test). Results with Picture Color Analyzer software: On the basis of the threshold value that was obtained from the control-group, 22 eyes (30.1%, n=73) in the patient-group were shown to have developed an increase in iris pigmentation. Conclusions Contrary to the previous studies that noted that the percentage of iris hyperpigmentation caused by travoprost in homochromic brown eyes was very low, our study showed that 35.6% iris hyperpigmentation did occur, which is a considerably higher percentage than that reported in whites.

To compare the effects of latanoprost and bimatoprost on central corneal thickness (CCT).A total of 188 eyes of 94 patients who were being followed in our hospital's glaucoma clinic and were receiving either latanoprost (55.3%) or bimatoprost (44.7%) monotherapy were recruited for the study. The data were collected prospectively from the patients, who were medicated with bimatoprost or latanoprost, at the initial diagnosis of glaucoma. Measurements were performed at the initial diagnosis, 6th, 12th, and 24th months. All the measurements were carried out by the same doctor between 9 AM and 11 AM, using Goldmann applanation tonometer for intraocular pressure (IOP) and ultrasound biopachymeter for CCT.There were no significant differences between the patient groups receiving latanoprost or bimatoprost for sex, age, baseline IOP, and CCT. The mean baseline CCT values were 559.5+/-35.3 mum for latanoprost group and 553.4+/-31.7 mum for bimatoprost group. CCT of both groups at 6, 12, and 24 months were significantly thinner when compared with baseline CCT. The percent reduction rates were 1.9+/-2.4% for latanoprost and 2.8+/-1.8% for bimatoprost in the 24th month.A significant reduction in CCT was observed at the 6th, 12th, and 24th months with latanoprost and bimatoprost. Serial CCT measurements in determining the IOP values may be helpful in the follow-up of prostaglandin analogs.

PURPOSE To assess the efficacy and safety of systematically switching a large number of hospital-based glaucoma patients from latanoprost to travoprost therapy. MATERIALS AND METHODS In this prospective observational study, patients on latanoprost were systematically switched to travoprost without washout and followed-up for 12 weeks. The main outcome measures were control of intraocular pressure (IOP), rate of switching back, and tolerability. IOP was measured at baseline (while on latanoprost), and at weeks 6 and 12 after switching to travoprost. Adverse effects were assessed and conjunctival hyperemia was graded using a standardized scale. RESULTS Ninety-three consecutive patients (mean age 63.3 +/- 12.1 y) were enrolled. Nine patients were lost to follow-up. Four patients (4.3%) were switched back to latanoprost after 6 weeks due to travoprost intolerance. There was no significant difference between mean IOP at baseline [16.4 +/- 3.4 mm Hg, 95% confidence interval (CI) 15.6-17.2] and that at week 6 (15.9 +/- 4.2 mm Hg, 95% CI 14.9-16.8) (P=0.2) and week 12 (16.4 +/- 5.7 mm Hg, 95% CI 15.1-17.7) (P=0.99). There was no significant difference in the mean hyperemia score at week 12 compared with baseline (P=0.09). The majority of patients (86.9%) felt that both medications were comparable in terms of degree of comfort; 5 felt that travoprost caused more redness. CONCLUSIONS In this study, when glaucoma patients were systematically switched from latanoprost to travoprost, the efficacy and safety of the 2 medications were found to be comparable. A high switch rate (95.2%) was achieved with average hyperemia scores being comparable.

Purpose To investigate the association between patterns of eye drop prescription and medication usage in patients with glaucoma. Patients and methods Sixty-seven Japanese patients with glaucoma who were prescribed topical antiglaucoma medications including a prostaglandin analogue bilaterally for >6 months at Nayoro City General Hospital, Nayoro, Japan, were included in the study. A self-administered, 5-item patient questionnaire was administered to determine how patients routinely use medications, including the method of eye drop administration, number of eye drops per instillation, accuracy of eye drop placement, weekly frequency of eye drop application, and their awareness of local side effects. The number of prostaglandin analogue bottles prescribed monthly was compared in each factor. Results The mean patient age was 74.4±10.0 years (range, 52 to 95 y; 39 women, 28 men). The mean duration of glaucoma treatment was 4.2±3.2 years (range, 0.7 to 10.6 y). Patients who placed the eye drops outside the eye were prescribed significantly more bottles monthly (P=0.008). The other factors had no significant effect on the number of bottles prescribed monthly. Conclusions Patients with glaucoma who used eye drops incorrectly were routinely prescribed additional bottles of eye drops. Ophthalmologists should determine whether patients who request an unusual number of eye drops are using the eye drops correctly.

PURPOSE: To compare the efficacy of bimatoprost/timolol (BTFC) or travoprost/timolol (TTFC) fixed combinations on intraocular pressure (IOP) reduction in an Egyptian population. METHODS: Patients with primary open angle glaucoma were randomized to receive either BTFC or TTFC. IOPs were measured at baseline, 2 weeks, and 1, 2, 4, and 6 months. The primary outcome measure was the mean change in IOP from baseline at each visit. Secondary outcome measures included the incidence of adverse events. RESULTS: Eighty patients (80 eyes) were included finally: 40 eyes in each group. Baseline mean IOPs were 24.78±3.53 and 25.26±3.51 mm Hg for BTFC and TTFC, respectively (P=0.344). Both drops provided statistically significant IOP reductions from baseline at all visits (P

PURPOSE Upper eyelid sulcus deepening has recently been reported as an adverse effect of prostaglandin (PG) eye drop use. However, no data are available regarding the frequency of upper eyelid sulcus deepening caused by different types of PG eye drops. We used 5 types of PG eye drops in Japanese subjects and examined the frequency of appearance of upper eyelid sulcus deepening in these subjects. PATIENTS AND METHODS The study included 250 patients (250 eyes) diagnosed with primary open-angle glaucoma or ocular hypertension. Five healthy patients were included as controls. One eye of each patient was treated with one of the following PG eye drops for >3 months: latanoprost, travoprost, tafluprost, bimatoprost, and isopropyl unoprostone. A single-lens reflex camera was used to photograph the open eyelids. Three ophthalmologists independently judged the appearance of the deepened upper eyelid sulcus in the photographs of the 250 patients and 5 controls by comparing the right and left eyes. A subjective self-reported symptom questionnaire was also administered. RESULTS Upper eyelid sulcus deepening was objectively (photograph) and subjectively (questionnaire) noted in 24.0% and 12.0%, 50.0% and 24.0%, 18.0% and 10.0%, 60.0% and 40.0%, and 8.0% and 10.0% of the patients in the latanoprost, travoprost, tafluprost, bimatoprost, and unoprostone groups, respectively. It occurred more frequently (objectively and subjectively) in the bimatoprost group than in the latanoprost, the tafluprost, and the unoprostone groups (P

Purpose: To compare the daily versus the alternate day use of travoprost 0.004% in lowering the intraocular pressure (IOP) in patients with ocular hypertension. Methods: Fourteen patients with ocular hypertension in both eyes have been randomly assigned to receive travoprost 0.004% once a day in 1 eye and once every other day in the other eye. The main outcome measure was change in the mean of the IOPs measured at 9:00 AM, and 4:00 PM between baseline (before treatment) and measurement of IOPs at 1, 2, 4, 8, and 12 weeks after treatment. Results: After 3 months of treatment, daily use of travoprost 0.004% significantly reduced IOP (mean±standard error of mean) by 6.1±0.5 mmHg (P

The objective was to assess the long-term economic consequences of the medical management of glaucoma in the UK.The economic evaluation was conducted using the results from a 10-year Markov model based around 3 key triggers for a switch in medical therapy for glaucoma, namely: lack of tolerance (using hyperemia as a proxy); intraocular pressure (IOP) not meeting treatment benchmark; and glaucoma progression. Clinical data from a comprehensive systematic literature review and meta-analysis were used. Direct costs associated with glaucoma treatment are considered (at 2008/9 prices) from the perspective of the UK NHS as payer (outpatient/secondary care setting). Using this model, the economic consequences of 3 prostaglandin-based treatment sequences were compared.Drug acquisition costs account for around 8% to 13% of the total cost of glaucoma and, if ophthalmologist visits are included, amount to approximately £0.80 to £0.90 per day of medical therapy. The total long-term costs of all prostaglandin strategies are similar because of a shift in resources: increased drug costs are offset by fewer clinic visits to instigate treatment switches, and by avoiding surgery or costs associated with managing low vision. Under the latanoprost-based strategy, patients would have longer intervals between the need to switch therapies, which is largely due to a reduction in hyperemia, seen as a proxy for tolerance. This leads to a delay in glaucoma progression of 12 to 13 months. For every 1000 clinic appointments, 719 patients can be managed for 1 year with a latanoprost-based strategy compared with 586 or 568 with a bimatoprost or travoprost-based strategy.Drug acquisition costs are not a key driver of the total cost of glaucoma management and the cost of medical therapy is offset by avoiding the cost of managing low vision. Economic models of glaucoma should include the long-term consequences of treatment as these will affect cost-effectiveness. This analysis supports the hypothesis that the economic and clinical benefits can be optimized by minimizing therapy switches.

PURPOSE To assess the efficacy and tolerability of benzalkonium chloride (BAK)-free travoprost after transition from BAK-preserved latanoprost. METHODS This was a prospective, open-label, multicenter study in patients with open-angle glaucoma or ocular hypertension who had been treated with latanoprost monotherapy for at least 3 months. The main outcome measures were superficial punctate keratopathy (SPK), hyperemia, and intraocular pressure (IOP). At baseline, 1, 3, and 12 months, hyperemia, SPK, and IOP were consecutively assessed. Hyperemia was assessed using a 4-grade scale. SPK was assessed by fluorescence staining observed by Area-Density classification. The IOP was measured by Goldmann applanation tonometry. RESULTS One hundred and fourteen patients participated in this study. Twenty-eight patients discontinued medications by 1 month. Sixty-seven patients completed the study. Transition from latanoprost to BAK-free travoprost showed no significant effect on hyperemia at 1 month, but showed significant decreases at 3 and 12 months compared with baseline (P

PURPOSE To evaluate bimatoprost versus latanoprost and timolol fixed combination (LTFC) over the 24-hour diurnal curve in patients who switched from timolol. METHODS In this prospective, observer-masked, randomized clinical trial, 64 patients whose intraocular pressures (IOPs) were not effectively controlled with timolol were enrolled. At pretrial visit IOPs and central corneal thickness were measured. After the baseline visit, timolol was replaced by bimatoprost or LTFC. IOPs were recorded at 8 AM, noon, 4 PM, 8 PM, midnight, and 4 AM at baseline, week 8, and week 16 visits. RESULTS At baseline and week 8 visits, there was no significant difference between the LTFC and bimatoprost group for the mean IOPs at 6 time points in 24 hours, the mean diurnal IOP, and range of diurnal IOP. At week 16, the mean IOP of the bimatoprost group (15.7±2 mm Hg) at 8 AM and 12 o' clock, midnight, was statistically significantly lower than that of the LTFC group (16.8±1.5 and 16.9±1.7 mm Hg; P=0.03 and 0.002). A statistically significant difference was not found between the proportions of patients who had 15% and 20% decrease in mean diurnal IOP and the mean daytime, nighttime, diurnal IOP reductions of the 2 study groups at weeks 8 and 16 (P>0.05). In the bimatoprost group punctate epitheliopathy, conjunctival hyperemia, and lid erythema were found to be more frequent. CONCLUSIONS The LTFC and bimatoprost therapies were equally effective in maintaining IOP at lower levels during the 24-hour period in patients who switched from timolol therapy. Adverse events were more frequent with bimatoprost therapy.

In 2, identical, double-masked, parallel studies of 3 month duration, the safety and efficacy of the fixed combination (FC) of 0.03% bimatoprost (BIM) and 0.5% timolol (TIM, Ganfort, Allergan, Inc) was clinically and statistically significantly more effective than BIM and TIM for most comparisons, a

PURPOSE To investigate the influence of personality traits, depression, and training on objectively measured adherence to once-daily prostaglandin analog medication. METHODS Adherence was measured with the Travalert Dosing Aid on 58 consecutive, regularly followed-up glaucoma patients already on self-administered travoprost. Before the 3-month data-collection period all patients received training on use of the device. Psychologic characteristics were measured using the State-Trait Anxiety Inventory, Eysenck Personality Questionnaire, and Beck Hopeless Scale and Depression Inventory. An adherent day was defined as travoprost instillation at 9 PM +/-2 hours. RESULTS Adherence was 77% for the total period. Social desirability was higher than normal (U test, P

Subclinical inflammation may be observed in patients using topical antiglaucomatous drugs. The objective of this study was to investigate inflammation in conjunctiva of glaucoma patients using prostaglandin analogs, by the detection of an immunogenetic marker (HLA-DR) and compare the effect of 3 different drugs: latanoprost, bimatoprost, and travoprost in the induction of this inflammation.Thirty-three patients with primary open-angle glaucoma were evaluated without and with prostaglandin analogs topical therapy. Imprints of conjunctival cells were obtained, fixed on glass slides, and prepared for immunohistochemical analysis.Before the use of prostaglandin analogs, 4 of the 33 patients evaluated presented expression of HLA-DR in the conjunctiva (mild). After 1 month on prostaglandin analog treatment, all but 1 patient presented HLA-DR staining. HLA-DR expression of these 32 patients was scored as mild (19 patients), medium (11 patients), or intense (2 patients). The differences were statistically significant both when the presence and the increased expression of HLA-DR were considered (P0.001). When the 3 different groups were analyzed (latanoprost, bimatoprost, and travoprost) no statistically significant difference was found (P=0.27).The use of prostaglandin analogs eye drops provokes a subclinical inflammatory reaction, observed by HLA-DR expression, even after a short period of treatment, independently of the class of the prostaglandin analogs used.

This systematic meta-analysis was performed to evaluate the intraocular pressure (IOP) lowering effects and tolerability of latanoprost, bimatoprost, and travoprost.Clinical trials published up to July 2006 were thoroughly searched using all available databases and resources. The inclusion criteria were prospective randomized controlled clinical trials; patients with primary open-angle glaucoma or ocular hypertension; and prostaglandin monotherapy, without systemic/ocular medications or laser/surgery that could affect IOP within the past 3 months. Study quality was assessed with the Jadad scoring system, and potential bias was eliminated by robust statistical and independent reviews of publications. The main outcome measures were efficacy assessed by IOP (taken at 8 AM, noon, 4 PM, and 8 PM) change at 3 months from baseline and tolerability assessed by the incidence of conjunctival hyperemia.Eight trials were identified (n=1610 patients). IOP change from baseline was statistically significantly greatest with bimatoprost, compared with latanoprost at all time points [weighted mean (WM) 8 AM: WM=0.50 mm Hg; P=0.05; 95% confidence intervals (CIs) 0.01-0.99; noon: WM=1.17 mm Hg; P0.001; 95% CI 0.68-1.66; 4 PM: WM=0.78 mm Hg; P=0.003; 95% CI 0.26-1.29; 8 PM: WM=0.67 mm Hg; P=0.04; 95% CI 0.02-1.32], and with travoprost during the daytime (8 AM: WM=1.02 mm Hg; P=0.004; 95% CI 0.32-1.72; noon: WM=0.86 mm Hg; P=0.02; 95% CI 0.12-1.59). Latanoprost and travoprost were comparable in their ability to reduce IOP at all time points (Por=0.82). The incidence of hyperemia was less with latanoprost and travoprost [latanoprost vs. bimatoprost: relative risk=0.59; P0.001; 95% CI 0.50-0.69; travoprost vs. bimatoprost: relative risk=0.84; P=0.05; 95% CI 0.70-1.00].The findings suggest a greater efficacy of bimatoprost compared with latanoprost and travoprost, although the incidence of hyperemia was lower with the latter 2 agents.

Purpose To compare the duration of action of travoprost ophthalmic solution 0.004% (Travatan Z) formulated without benzalkonium chloride (BAK) to travoprost ophthalmic solution 0.004% formulated with BAK (Travatan). Methods This was a prospective, randomized, double-masked study. Patients with open-angle glaucoma or ocular hypertension were randomized to receive 2 weeks of once-daily therapy with travoprost BAK-free or travoprost with BAK. Patients received the last dose of medication on day 13 and then intraocular pressure (IOP) was assessed every 12 hours for 60 hours. Statistical analysis included change in IOP from baseline for each group and comparison of mean IOP between groups. Results Of the 109 patients enrolled, 106 patients completed the study. Untreated mean baseline IOP at 8 AM was 26.9 mm Hg in the travoprost BAK-free group and 27.1 mm Hg in the travoprost with BAK group. At 12, 24, 36, 48, and 60 hours after the last dose, mean IOP in the travoprost BAK-free group was 18.7, 17.2, 19.5, 18.7, and 20.8 mm Hg, respectively; whereas mean IOP in the travoprost with BAK group was 18.5, 16.8, 19.7, 18.0, and 20.8 mm Hg, respectively. Mean IOP at all time points after the last dose of medication was >6 mm Hg lower than the 8 AM baseline in both groups. Between-group differences were within +/-0.6 mm Hg at all postdose time points. There were no statistically significant differences between the 2 treatment groups at baseline or at any postdose time point. Drug-related side effects were uncommon, mild in intensity, and comparable between groups. Conclusions Travoprost without BAK has similar IOP-lowering efficacy and safety compared with travoprost preserved with BAK. Both formulations of travoprost have a prolonged duration of action, with statistically and clinically significant reductions from baseline persisting up to 60 hours after the last dose.

PURPOSE: To evaluate the safety and efficacy of a fixed combination (FC) of bimatoprost (BIM) and timolol (TIM) compared with each of the active components for 3 months. PATIENTS AND METHODS: Two double-masked, randomized, multicenter parallel studies of FC (once-daily, mornings), BIM (once-daily, evenings), or TIM (twice-daily) were conducted in 1061 patients with glaucoma or ocular hypertension. RESULTS: Mean diurnal decreases from baseline intraocular pressure (IOP) at month 3 were 8.1, 7.9, and 6.4 mm Hg for the FC, BIM, and TIM groups, respectively. The proportion of patients with a mean diurnal percent reduction from baseline in IOP of more than 20% across all visits was 81.8% (436/533), 72.1% (191/265), and 49.8% (131/263) for the FC, BIM, and TIM groups, respectively (P

PURPOSE: To evaluate the efficacy of latanoprost, bimatoprost, and travoprost given in the evening over the 24-hour curve in newly diagnosed open-angle glaucoma patients. METHODS: This 8-week, randomized, parallel group, masked evaluator study compared the efficacy of once daily administration of latanoprost 0.005%, bimatoprost 0.03%, and travoprost 0.004% ophthalmic solutions. After enrollment at baseline, 48 patients were randomized to 3 treatment groups: latanoprost (n=17), bimatoprost (n=16), and travoprost (n=15). At baseline and 8 weeks of therapy, masked evaluators measured intraocular pressure (IOP) at 8 AM, 10 AM, 1 PM, 4 PM, 8 PM, 11 PM, and 3 AM. RESULTS: Baseline mean IOP levels were similar across the groups. By week 8, reductions were observed in all 3 groups (P

To determine the mechanism by which travoprost 0.004% reduces intraocular pressure (IOP) in patients with ocular hypertension or primary open angle glaucoma.This is a randomized, double-masked, placebo-controlled, single center study of 26 patients scheduled for 3 visits (baseline, day 15, and days 17 to 18) following screening.After appropriate washout of all ocular medications, baseline IOPs were taken and travoprost 0.004% was administered once-daily in the evening for 17 consecutive doses to 1 eye and its vehicle to the fellow eye in a randomized, masked fashion. On day 15, beginning 12 hours after the 14th consecutive dose, IOP was measured by pneumatonometry, aqueous flow and outflow facility by fluorophotometry, and episcleral venous pressure by venomanometry. Uveoscleral outflow was determined by mathematical calculation. Two days later, the last drop of drug/vehicle was given at 2000 hours. Fluorophotometry and tonometry measurements were repeated between 2200 and 0600 hours. Treated eyes were compared with contralateral control eyes or baseline measurements, and daytime measurements were compared with nighttime measurements using paired t tests.Travoprost-treated eyes showed a significant (P0.001) decrease in daytime IOP compared with baseline (26%) or to vehicle-treated eyes (22%), and an increase in daytime outflow facility (P=0.001; 64%). The increase in uveoscleral outflow was not statistically significant. At night, the IOPs of travoprost-treated eyes remained 21% to 24% below baseline daytime values. Seated and supine IOPs in control eyes were significantly (P0.04) lower at 2200 hours than 1700 hours (P0.04). Supine IOPs were higher than seated IOPs in both control and treated eyes (P0.001). Aqueous flow was significantly (P0.001) reduced at night in both travoprost (30%) and vehicle-treated (25%) eyes when compared with daytime values. No other comparisons were statistically significant.Travoprost seems to lower IOP by increasing trabecular outflow facility. An effect on uveoscleral outflow cannot be ruled out.

Purpose To compare the safety and efficacy of travoprost 0.004% without benzalkonium chloride (BAC) to that of the marketed formulation of travoprost 0.004% in patients with open-angle glaucoma or ocular hypertension. Methods The study was a double-masked, randomized, parallel group, multicenter, noninferiority design. Adult patients with open-angle glaucoma or ocular hypertension with qualifying intraocular pressure (IOP) on 2 eligibility visits received either travoprost 0.004% with BAC (n=346), or travoprost 0.004% without BAC (n=344) dosed once-daily each evening. Patients were followed for a period of 3 months. IOP measurements at 8 AM, 10 AM, and 4 PM were taken at study visits on week 2, week 6, and month 3. Results Mean IOP reductions, across all 9 study visits and times ranged from 7.3 to 8.5 mm Hg for travoprost 0.004% without BAC and from 7.4 to 8.4 mm Hg for travoprost 0.004% with BAC. Statistical equivalence was also demonstrated for the comparison of mean IOP changes; 95% confidence limits were within ±0.8 mm Hg at 9 of 9 study visits and times in both the per protocol and intent-to-treat data sets. Adverse events and the number of patients discontinued owing to adverse events were similar for both treatment groups. Adverse events due to hyperemia occurred in 6.4% and 9.0% of patients treated with travoprost 0.004% without BAC and travoprost 0.004% with BAC, respectively. Conclusion Travoprost 0.004% without BAC is equivalent to travoprost 0.004% with BAC in both safety and efficacy.

To evaluate 24-hour continuous intraocular pressure (IOP) monitoring with a telemetric contact lens sensor (CLS) to detect prostaglandin-induced IOP reduction.In this prospective interventional study 9 ocular hypertensive and primary open-angle glaucoma patients were washed out from IOP-lowering medication for 6 weeks. One study eye per patient underwent 3 baseline 24-hour measurement curves 4 days apart: 2 curves with Sensimed Triggerfish CLS and 1 curve with Goldmann applanation tonometry (GAT). Then the patients received travoprost monotherapy for 3 months. The 24-hour CLS and GAT curves were repeated on the study eyes under treatment at the end of the third month.The 24-hour GAT IOP (mean±SD) decreased from 22.91±5.11 to 18.24±2.49 mm Hg (P0.001). In contrast, the means of the 3 CLS curves showed no significant difference (152.94, 142.35, and 132.98 au, P=0.273). No difference was seen when the SD values of the 3 CLS curves were compared (133.51, 132.18, and 110.98 au, P=0.497). All CLS curves showed an increasing time trend (P≤0.001). Correlation of all 3 CLS curves of the individual eyes was high (r=0.726), but no correlation was seen between the corresponding CLS curve periods and GAT IOP values either at baseline (r=-0.223, P=0.546) or under treatment (r=0.320, P=0.402). No difference was seen between the erect/sitting (waking) and supine (sleeping) period CLS values (P0.05).Our results suggest that the current CLS technique cannot be clinically used to monitor IOP decrease induced by topical medication in glaucoma, and has limited value in identification of transient IOP elevation periods.

Purpose To evaluate the accuracy of a prototype electronic device for recording eye drop usage. Participants and methods Ten volunteers were randomly assigned to one of five usage patterns designed to mimic common patterns of use in glaucoma patients from 100% compliant to 50% compliant. All participants agreed to adhere to a pre-determined "dosing" schedule for 15 days using the monitoring/reminder device to instill artificial tears. Participants also recorded drop usage in a diary. The main outcome measures were device accuracy and reproducibility. Device accuracy was defined as the magnitude of the difference between the diary and device output for three variables: date, number of drops, and instillation time. Results Date stamping by the device was 100% accurate. The mean +/- SD time difference between the device and the diary was -2.0 +/- 19.7 minutes when data from all participants was pooled. In seven of the ten participants, the device did not record at least one drop. The mean +/- SD difference in the number of drops recorded by the device minus the diary was 0.16 +/- 0.97 when data from all participants was pooled. Conclusions The prototype compliance reminder/monitoring device may underestimate compliance in some patients. The date and time stamping mechanisms were generally accurate and reproducible.

The primary objective of this study was to compare the intraocular pressure (IOP)-lowering efficacy of travoprost 0.004%/timolol 0.5% fixed combination to the concomitant administration of travoprost 0.004% (TRAVATAN) and timolol 0.5% in subjects with open angle glaucoma or ocular hypertension.This was a randomized, multicenter, double-masked, active-controlled, parallel group study. Three hundred sixteen patients with open angle glaucoma or ocular hypertension were randomly assigned to travoprost 0.004%/timolol 0.5% ophthalmic solution fixed combination once daily in the morning or concomitant administration of timolol 0.5% once daily in the morning and travoprost 0.004% ophthalmic solution once daily in the evening. The efficacy and safety of the fixed combination were compared with concomitant therapy over three months. The primary efficacy outcome measure was mean intraocular pressure.Both travoprost 0.004%/timolol 0.5% fixed combination and the concomitant administration of travoprost 0.004% and timolol 0.5% produced statistically significant reductions from baseline in IOP, with mean IOP ranging from 15.2 to 16.5 mm Hg in the patients using travoprost 0.004%/timolol 0.5% fixed combination compared with 14.7 to 16.1 mm Hg in the concomitant group. The upper 95.1% confidence limit for the differences in mean IOP (fixed combination minus concomitant) wasor =1.5 mm Hg at 7 of 9 visits, including all three 8 AM time points, 24-hours post-dose. Mean IOP reductions from baseline ranged from 7.4 to 9.4 mm Hg in the fixed combination group compared with 8.4 to 9.4 mm Hg with concomitant therapy. Safety analysis demonstrated equivalent safety between the two treatment groups.A fixed combination of travoprost 0.004% and timolol 0.5% produced clinically relevant IOP reductions in patients with open angle glaucoma or ocular hypertension that were comparable to concomitant therapy with its components. Safety and tolerability of the fixed combination were also equivalent to concomitant therapy. Travoprost 0.004%/timolol 0.5% fixed combination offers IOP reduction equivalent to concomitant therapy, with potential benefits that include convenience (fewer bottles and drops per day), improved compliance, cost savings (based on fewer co-payments), and elimination of potential washout effects.

PURPOSE To evaluate short-term conjunctival and corneal punctate staining with latanoprost, bimatoprost, and travoprost in healthy individuals. MATERIALS AND METHODS A single centered, active-controlled, three-period crossover comparison that evaluated conjunctival and corneal punctate staining, by grade and individual stains, in healthy subjects after dosing for five days in one eye with latanoprost, bimatoprost, or travoprost. Staining was evaluated at 24-hour trough (Hour 0) and at Hour 1 after dosing. RESULTS Twenty-eight subjects completed this study. This study found that there was no significant difference by ANOVA for the number of individual corneal punctate stains either at trough (latanoprost 22.6 +/- 25.4, bimatoprost 16.8 +/- 25.6, and travoprost 21.1 +/- 26.0 mm Hg) (P = 0.33) or at 1 hour after dosing (latanoprost 23.8 +/- 26.3 bimatoprost 18.2 +/- 25.2, and travoprost 26.1 +/- 26.1 mm Hg) (P = 0.75) among treatment groups. No significant differences existed among treatment groups in the study eye compared with the non-study eye or to the study eye at Hour 0 or Hour 1 or to the period initiation or baseline visits (P > 0.05). Several significantly different comparisons, inconsistent in nature, were observed for the nasal and temporal conjunctival staining between the treatment groups. There were no differences in unsolicited or solicited adverse events between groups. CONCLUSION This study suggests that, in healthy subjects after short-term treatment, latanoprost, bimatoprost, and travoprost demonstrate generally similar ocular surface epithelial staining characteristics.