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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<0.001). BTFC provided greater significant mean IOP reductions from baseline than TTFC at each visit (P<0.001). Mean IOP reductions were 11.34 and 6.42 mm Hg at 2 weeks (P=0.000), and 11.17 and 7.89 mm Hg at 6 months (P=0.001) for BTFC and TTFC, respectively. IOPs at 2 weeks were ≤18 mm Hg in 36 (90.8%) versus 22 (55%) eyes and ≤16 mm Hg in 28 (70%) versus 16 (40%) eyes (P<0.001), and at 6 months, ≤18 mm Hg in 38 (95%) versus 28 (70%) eyes and ≤16 mm Hg in 30 (75%) versus 18 (45%) eyes for BTFC and TTFC, respectively (P<0.001)., Conclusion: Both drops provided effective IOP reduction that was greater and patients were more likely to achieve lower target pressures with BTFC than with TTFC.

Purpose: The aim of the study was to evaluate the long-term 24-hour intraocular pressure (IOP) efficacy of travoprost monotherapy in primary open-angle glaucoma patients., Patients and Methods: A total of 36 previously untreated primary open-angle glaucoma patients were enrolled in this 5-year study. Patients underwent an untreated 24-hour IOP evaluation. Subsequently all patients were assigned to topical therapy with travoprost 0.004% eye-drops preserved with benzalkonium chloride (Travatan, Alcon Laboratories Inc., Fort Worth, TX) administered once in the evening (8:00 PM) in both eyes. All patients were then scheduled for a 24-hour IOP assessment approximately 12 months after the baseline visit. This schedule of follow-up was maintained for the whole duration of the trial. The predetermined range of target IOP reduction selected in this cohort of patients ranged between 20% and 30%., Results: A total of 34 patients completed all phases of the investigation. The mean survival time was 57.3±2.0 months and the cumulative survival rate was 0.82±0.6 at 60 months. Travoprost reduced the mean 24-hour IOP from 23.4±1.7 mm Hg at baseline to 16.8±2.4 mm Hg (28.4%), 16.8±2.5 mm Hg (28.1%), 16.8±2.4 mm Hg (28.5%), 16.7±2.5 mm Hg (28.6%), and 16.9±2.4 mm Hg (27.8%), respectively at the end of the first, second, third, fourth, and fifth year follow-up. No drug-related serious adverse events were registered during the study., Conclusions: The present study demonstrated the long-term 24-hour efficacy of travoprost for the treatment of primary open-angle glaucoma.

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<0.001) and alternate day use by 5.9±0.3 mmHg (P< 0.001) adjusted from an overall baseline of 24.3±0.5 mm Hg. The difference in the IOP-lowering effect was not statistically significant (P<0.05)., Conclusions: Alternate day use of travoprost 0.004% was as safe and effective as its daily use in lowering the IOP in patients with ocular hypertension.

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.

Purpose: To compare the efficacy of brinzolamide versus placebo when added to travoprost/timolol fixed combination (TTFC) in uncontrolled patients., Patients and Methods: 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., Results: 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)., Conclusions: 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.

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<0.05). The prevalence of SPK, especially its severity score, at all points were significantly reduced compared with baseline (P<0.05). The IOP at baseline and at 12 months after transition was 14.9±3.4 and 14.3±3.3 mm Hg, indicating a significant reduction after the change in regimen compared with baseline (P<0.05)., Conclusions: Treatment for 12 months with BAK-free travoprost after BAK-preserved latanoprost resulted in fewer ocular surface complications, as indicated by the reduced prevalence of SPK and decreased hyperemia, and no clinically relevant changes in IOP. BAK-free travoprost may have beneficial effects on the ocular surface while showing IOP-lowering efficacy comparable with BAK-preserved eye drops.

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.

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<0.0001). Seven patients (12.1%) showed mild-to-moderate depression, which was not significantly associated with decreased adherence (Kruskal-Wallis test, P=0.071). Severity of glaucoma, number of ocular and systemic medications, satisfaction with the recording device, and socio-economic characteristics had no influence on adherence., Conclusions: Objectively measured adherence to once-daily prostaglandin analog medication was good, and not influenced by treatment characteristics or patient factors including mild-to-moderate depression. The elevated social desirability suggests that self-reported adherence is not a reliable measure of adherence in glaucoma.

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., 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, chi(2) 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.

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<0.001 for FC vs. BIM and FC vs. TIM). The proportion of patients achieving an IOP of less than 18 mm Hg at all time points was 39.2% (209/533), 28.7% (76/265), and 12.2% (32/263) for the FC, BIM, and TIM groups, respectively (P=0.003 for FC vs. BIM, and P<0.001 for FC vs. TIM). The most commonly reported treatment-related adverse event was conjunctival hyperemia, with the greatest incidence in BIM (38.5%, 102/265), followed by FC (22.7%, 121/533, P<0.0001 vs. BIM) and TIM (6.8%, 18/263; P<0.001 vs. FC)., Conclusions: FC was statistically significantly more effective than BIM or TIM for most comparisons, and safer than BIM with respect to common ocular adverse events. FC represents a convenient, therapeutic advantage over separate bottles.

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 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<0.001 for each). Travoprost-treated patients' IOP levels were reduced 8.7 and 8.1 mm Hg at 8 and 10 AM, respectively. Latanoprost-treated patients experienced 4.8 and 5.3 mm Hg reductions, whereas bimatoprost-treated patients experienced 5.5 and 4.9 mm Hg reductions at these time points. The amount of IOP reduction seen at 8 and 10 AM in travoprost group was significantly higher when compared with latanoprost and bimatoprost-treated group (P<0.001)., Conclusions: Latanoprost, bimatoprost, and travoprost were comparable in their ability to reduce IOP in open-angle glaucoma patients. On the basis of our data, the IOP reduction of these drugs is indistinguishable within statistical parameters.

Purpose: To determine the mechanism by which travoprost 0.004% reduces intraocular pressure (IOP) in patients with ocular hypertension or primary open angle glaucoma., Design: 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., Methods: 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., Results: Travoprost-treated eyes showed a significant (P<0.001) 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 (P<0.04) lower at 2200 hours than 1700 hours (P<0.04). Supine IOPs were higher than seated IOPs in both control and treated eyes (P<0.001). Aqueous flow was significantly (P<0.001) reduced at night in both travoprost (30%) and vehicle-treated (25%) eyes when compared with daytime values. No other comparisons were statistically significant., Conclusions: 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.

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.

Purpose: 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., Methods: 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., Results: 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) was < or =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., Conclusions: 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.

Purpose: This 9-month study compared the intraocular pressure (IOP)-lowering efficacy and safety of once-daily travoprost ophthalmic solutions (0.0015% and 0.004%) with twice-daily timolol 0.5%., Patients and Methods: This study was conducted using a double-masked, randomized, parallel-group design; adult patients with open-angle glaucoma or ocular hypertension (IOP between 24 and 36 mm Hg, inclusive at 9 am and between 21 and 36 mm Hg, inclusive, at 11 am and 4 pm on two eligibility visits after an appropriate washout of previous treatments). In both eyes, the travoprost vehicle (placebo) was instilled at 9 am and travoprost (0.0015% or 0.004%) was instilled at 9 pm, or timolol 0.5% was instilled at both times. The primary efficacy variable was mean IOP measured at 9 am, 11 am, and 4 pm at baseline and follow-up visits., Results: Five hundred seventy-three patients were randomized to the study treatments. Mean IOP, which was combined across study visits, was lower with travoprost 0.004% than with timolol 0.5% at 9 am (P = 0.0246), 11 am (P = 0.0039), and 4 pm (P = 0.0004). Intraocular pressure was lower with travoprost 0.004% than with travoprost 0.0015% at 11 am (P = 0.0314), the time of peak drug activity. Mean IOP was consistently lower with travoprost 0.0015% than with timolol 0.5%. Mean IOP reductions from baseline were significantly (P less than equal 0.0001) greater with travoprost 0.004% (8.0-8.9 mm Hg) than with timolol 0.5% (6.3-7.9 mm Hg). The most frequent related adverse events were hyperemia, pruritus, discomfort, pain, and iris pigmentation changes. The local tolerance was better in the timolol group compared with patients receiving travoprost. There were no serious unexpected treatment-related adverse events in any group., Conclusions: Travoprost 0.004% reduced diurnal mean intraocular pressure significantly more than timolol 0.5%. Both concentrations of travoprost were well tolerated and safe for use in patients with open-angle glaucoma or ocular hypertension.