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Introduction: To evaluate the intraocular pressure (IOP)-lowering efficacy and safety of a triple fixed-combination of bimatoprost, brimonidine, and timolol (TFC) in patients with glaucoma or ocular hypertension (OHT) treated with fixed-combination or unfixed brimonidine and timolol therapy (dual-combination therapy). Methods: In this multicenter, open-label, phase 3 study, patients who received 4– 8 weeks of dual-combination therapy twice daily and had an IOP > 18 and < 34 mmHg in at least one eye were switched (at baseline) to treatment with TFC twice daily for 12 weeks. At Weeks 4, 8, and 12 on TFC, IOP was assessed at Hours 0, 2, and 8. Primary efficacy variable: mean diurnal IOP change from baseline in the study eye at Week 12 (modified intent-to-treat [mITT] population). Sensitivity (per-protocol [PP] population) and subgroup (≤ 65 vs > 65 years) analyses were performed. Safety, including adverse events (AEs), was assessed at each visit. Results: Of 126 patients enrolled, 121 and 103 formed the mITT/safety and PP populations, including 109 (90.1%) and 94 (91.3%) who completed the study, respectively. In the mITT/safety population, mean age was 58.6 years. Patients had open-angle glaucoma (51.2%), angle-closure glaucoma with patent iridotomy (36.4%), and/or OHT (13.2%). At Week 12, the mean diurnal change in IOP from dual combination-treated baseline was statistically significant (P< 0.001) with TFC in the mITT (– 3.98 mmHg) and PP (– 4.22 mmHg) populations. Results were similar at all visits, regardless of the age subgroup. The most frequent treatment-related AEs were conjunctival hyperemia (14.0%) and dry eye (4.1%); 5.8% of the patients discontinued treatment due to ocular AEs. Conclusion: TFC offers a beneficial therapeutic alternative for patients with glaucoma or OHT whose IOP is not sufficiently controlled with dual-combination therapy. Safety and efficacy findings support those of published studies of TFC in primary open-angle glaucoma and OHT, despite differences in study designs. [ABSTRACT FROM AUTHOR]

Purpose: To study topical timolol (0.5%) as a first-line treatment in ophthalmic pyogenic granuloma (PG) in terms of safety and efficacy.Methods: This was a prospective, interventional, single-arm study conducted at a tertiary eye care hospital in central India. Only new cases of PG were counseled to get enrolled in the study. A total of 40 patients were analyzed in the study. Topical timolol eye drop (0.5%) was started in each patient twice daily for 4-6 weeks duration. The patients were divided into five categories according to the percentage reduction in the size of PG as follows: i) 80-100% reduction - excellent responders, ii) 60-80% - good, iii) 40-60% - satisfactory, iv) 20-40% - poor, and v) <20% - very poor/nonresponder. After 6 months of starting treatment final evaluation was done.Results: The mean age of the patients was 23.5 ± 13.3 years. Etiology of the disease included chalazion (n = 11, 27.5%), trauma (n = 2, 5%), surgery (n = 7, 17.5%), foreign body (n = 2, 5%), and idiopathic (n = 18, 45%). An excellent response was achieved in 31 (77.5%) patients. Twenty-seven (67.5%) patients had complete resolution of lesions within 6 weeks. Recurrence of the lesion was not noticed in any patients.Conclusion: Timolol 0.5% in topical form is a good treatment option for ophthalmic PG in all age groups. The treatment has no adverse effects when given to suitable individuals for a limited period. [ABSTRACT FROM AUTHOR]

Purpose: The aim of this study was to analyze the effect of timolol maleate (0.5%) eye drops in the treatment of myopic regression after laser-assisted in-situ keratomileusis (LASIK).Methods: The study was conducted at a tertiary care eye hospital in north India between April 2017 & March 2018 as a prospective interventional study. Patients who underwent uneventful myopic LASIK with hansatome mechanical keratome and presented with regression were included in the study. Baseline demographic characteristics, time to presentation with regression best-corrected visual acuity (BCVA), refraction, intraocular pressure, central corneal thickness and keratometry were recorded at baseline and at each follow-up visit. The enrolled patients were prescribed timolol maleate (0.5%) eyedrops twice daily. They were followed up every month till 3 months on timolol maleate (0.5%) eyedrops and at 6 months post stopping the treatment.Results: Twenty-nine eyes of 15 patients were enrolled in the study. Mean pre LASIK spherical equivalent (SE) was - 7.48 ± 2.9 Diopters (Range-3.125 to -11.75 Diopters) and mean regression spherical equivalent was -1.02 ± 1.1 Diopters. There was a decrease in mean SE from presentation (intervention start point) up to 6 months follow-up (-1.34 ± 0.89 to -0.30 ± 0.29 Diopters). While posterior corneal curvature (K1 and K2 Back) changed significantly over treatment period (P = 0.0029, P = 0.0024 respectively), changes in anterior corneal curvature (K1 and K2 Front) were not significant (P = 0.05, P = 0.06 respectively). Central corneal thickness (CCT) and intraocular pressure (IOP) did not change significantly over treatment course.Conclusion: Timolol maleate (0.5%) eyedrop is an effective modality for the treatment of refractive regression post LASIK circumventing the need for laser re-treatment in such patients. The most probable mechanism is reversal of the anterior bowing of the cornea in response to intraocular pressure changes. [ABSTRACT FROM AUTHOR]

Aim: The aim of this study was to evaluate the efficacy and safety of preservative-free (PF) tafluprost compared with PF timolol in Indian subjects with open-angle glaucoma (OAG) or ocular hypertension.Methods: This was a randomised, multicentre, double-masked, phase III trial. Subjects aged 18-80 years, following washout of current medication, with intraocular pressure (IOP) ≥ 24 and ≤ 36 mmHg in at least one eye were randomised in a 1:1 ratio to 0.0015% PF tafluprost or 0.5% PF timolol for 4 weeks. IOP was measured at 08:00, 10:00 and 16:00 hours at baseline and at weeks 2 and 4. The primary efficacy end-point was the mean diurnal IOP change from baseline at week 4, and PF tafluprost was considered non-inferior to PF timolol if the upper bound of the 95% confidence interval (CI) for between-treatment differences was ≤ 1.5 mmHg. The secondary end-point was the proportion of subjects with ≥ 25% reduction in IOP from baseline at week 4.Results: In total, 190 subjects were randomised, 95 each, to PF tafluprost and PF timolol treatment. PF tafluprost was non-inferior to PF timolol with respect to diurnal IOP changes from baseline over 4 weeks. The mean PF tafluprost-PF timolol difference in the diurnal IOP change was -1.7 (95% CI -2.6 to -0.7), suggestive of superiority for PF tafluprost. The secondary end-point was achieved in a higher proportion of PF tafluprost group subjects. Both PF tafluprost and PF timolol were well-tolerated with similar incidences of adverse events.Conclusions: PF tafluprost was safe and efficacious in reducing IOP in Indian subjects. [ABSTRACT FROM AUTHOR]

Objective: The aim of this study was to evaluate the clinical spectrum and drugs responsible for ophthalmic adverse drug reactions (ADRs) in a tertiary-care hospital and to establish their causality, severity and preventability. Materials and methods: A prospective, observational study was conducted in the department of ophthalmology of a tertiary-care hospital from September 2012 to February 2014. Demographic details, clinical pattern and causal drug groups were recorded on a case-record form. Ophthalmic ADRs were assessed for causality, severity, preventability and economic impact. Results: A total of 114 ophthalmic ADRs were reported, of which 86 were associated with topical drug instillation and 28 with systemic administration. The most commonly suspected drug group was antiglaucoma agents, followed by mydriatics and corticosteroids, and the most frequently suspected causal drugs were topical timolol and oral acetazolamide. Clinical presentations of ophthalmic ADRs included burning sensations in eyes, eyelid oedema, eye pain, conjunctival hyperemia and reduced visual acuity due to cataract. The majority of ophthalmic ADRs started within 1 week of therapy, were probably associated with the suspected causal drug, and were mild to moderate in nature, but none of the ADRs were preventable. From a patient's perspective, the mean cost per ophthalmic ADR was 319.07 Indian rupees (US$5.19). Conclusion: Ophthalmic ADRs can occur as a result of the active ingredient and/or preservatives in ophthalmic solutions. Although the incidence of ophthalmic ADRs is low, mild to moderate ADRs can result into substantial functional impairment. Increasing the general awareness of clinicians and patients regarding ophthalmic ADRs would go a long way towards preventing and identifying these reactions. [ABSTRACT FROM AUTHOR]

Aim: This study was designed to compare the bimatoprost/timolol combination and dorzolamide/timolol combination in glaucoma for efficacy, safety, and cost-effectiveness in a local population of Trichy in the state of Tamilnadu. Materials and Methods: Eight-week, randomized, parallel group, open-label study was conducted on 48 patients of open angle glaucoma or ocular hypertension. After initial clinical assessment and baseline investigations, bimatoprost/timolol combination (Group A) was prescribed to 22 patients (2 patients lost after initial assessment) and dorzolamide/ timolol combination (Group B) to 24 patients. The patients were reviewed after second and eighth weeks for cure rate and adverse drug reaction monitoring. Results: At the end of 8 weeks, the mean reduction in intraocular pressure from baseline was 13.04 mmHg (95% confidence interval (CI): 10.67-14.70) with bimatoprost/timolol combination once daily (P < 0.01) and 9.46 mmHg (95% CI: 7.47-10.5) with dorzolamide/ timolol combination twice daily. Both the treatments were safe. Cost-effective range of bimatoprost/timolol combination was lower than that of dorzolamide/timolol combination. Conclusion: The fixed combination of bimatoprost/timolol was slightly more effective than that of dorzolamide/timolol combination in reducing IOP, and both treatments were generally well tolerated. Bimatoprost/timolol combination was more cost-effective (costeffective analysis) than dorzolamide/timolol combination. [ABSTRACT FROM AUTHOR]

Objective: To assess the quality of timolol eye drops sold in Kinshasa, Democratic Republic of Congo (DRC)., Methods: Seven samples of timolol maleate 0.5% were purchased over the counter in seven randomly selected public pharmacies in 3 neighborhoods in Kinshasa. They were submitted to a quality assessment that included visual inspection, spectrophotometry, high performance liquid chromatography (HPLC), and bacteriologic assessment., Results: The samples came from France (n=2), India (n=2) and DRC (n=3). Overall, 3 (2 from India and 1 from the DRC) of the 7 samples, or 3 out of the 5 from developing countries, showed various abnormalities consistent with substandard drugs. One sample (India) demonstrated an incorrect pH, while 3 (2 from India and one from the DRC) had lower than stated volumes as well as lower than required concentrations of the active pharmaceutical ingredient. In addition, one sample from the DRC was bacteriologically contaminated., Conclusion: These results suggest that some timolol maleate eye drops from Congolese and Indian manufacturers sold in Kinshasa are of substandard quality. This may reflect deficiencies in the manufacturers and local authorities charged with regulation of the quality control and sale of pharmaceuticals. Passing a visual inspection does not necessarily indicate that a drug is not substandard. Analytical chemistry testing and bacteriologic analysis are required to determine with certainty the quality of the drug., (Copyright © 2021 Elsevier Masson SAS. All rights reserved.)