A One-Week Comfort Study of BID-Dosed Brinzolamide 1%/Timolol 0.5% Ophthalmic Suspension Fixed Combination Compared to BID-Dosed Dorzolamide 2%/Timolol 0.5% Ophthalmic Solution in Patients with Open-Angle Glaucoma or Ocular Hypertension

Purpose To compare the efficacy and safety of a newly developed ophthalmic solution containing carteolol 2% and pilocarpine (2% (CBS341A) with a timolol 0.5% and pilocarpine 2% fixed combination. Patients and Methods. A randomized, double-masked, multicenter study was conducted in 209 patients with primary open-angle glaucoma or ocular hypertension, whose intraocular pressure (IOP) was higher than 21 mm Hg on bet-blocker twice a day alone. The test medications were administered twice daily for 4 months. IOP was measured at 9 and 11 a.m. at the beginning of the study (with beta-blocker alone) and after one and four months of treatment. Adverse effects were recorded. Results Both combinations caused a similar, statistically significant decrease in IOP. At four months, in the CBS341A group a 2.4 mm Hg (9%) reduction in IOP was achieved at 9 a.m. and 4.1 mm Hg (17.3%) at 11 a.m. compared with respectively 3 mm Hg (11%) and 4.5 mm Hg (19.5%) in the timolol-pilocarpine group. No statistical difference was observed between the two groups in safety and efficacy. Conclusions The carteolol-pilocarpine combination appears as safe and as effective as the timolol-pilocarpine combination in the medical treatment of primary open-angle glaucoma or ocular hypertension.

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Multicentre comparative clinical trial of the safety and efficacy of a 0.5% timolol-2% dorzolamide-0.2% brimonidine ophthalmic solution in fixed combination (formulated by Laboratorios Sophia S.A. de C.V.) versus Cosopt® in open angle glaucoma or ocular hypertension

http://isrctn.org/> ◽

10.1186/isrctn26988657 ◽

2012 ◽

Author(s):

Leopoldo Baiza-Duran

Keyword(s):

Clinical Trial ◽

Ocular Hypertension ◽

Fixed Combination ◽

Open Angle Glaucoma ◽

Ophthalmic Solution ◽

Open Angle ◽

Safety And Efficacy ◽

Comparative Clinical Trial

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A Comparative Analysis of the Efficacy and Safety of fixed Combinations of Latanoprost/Timolol vs Dorzolamide/Timolol in Primary Open Angle Glaucoma or Ocular Hypertension

Journal of Postgraduate Medicine Education and Research ◽

10.5005/jp-journals-10028-1039 ◽

2012 ◽

Vol 46 (4) ◽

pp. 172-176

Author(s):

Sukhsagar Ratol ◽

Rani Walia ◽

Mridu Chaudhry

Keyword(s):

Ocular Hypertension ◽

Primary Open Angle Glaucoma ◽

Fixed Combination ◽

Open Angle Glaucoma ◽

Eye Drops ◽

Open Angle ◽

Once Daily ◽

Group 2 ◽

Diurnal Iop ◽

Group 1

ABSTRACT Background Glaucoma is a leading cause of irreversible blindness. The fundamental problem in medical management of glaucoma is of patient compliance. An ideal drug or a drug combination is needed to slow the progression of this majorly symptomless disease. Aim To compare the efficacy and tolerability of the fixed combination latanoprost and timolol instilled once daily in the evening vs fixed combination of dorzolamide and timolol instilled twice daily in primary open angle glaucoma or ocular hypertension. Materials and methods A 12-week, randomized, open, parallel group study including 50 patients with primary open angle glaucoma or ocular hypertension was conducted at a tertiary care hospital. Patients were randomized to group 1, (fixed combination (FC) latanoprost and timolol eye drops, once daily in evening) and group 2, (FC dorzolamide and timolol eye drops, twice daily). At baseline, 2, 4 and 12 weeks, IOP was recorded at 9 AM and 12 noon. The difference in IOP reduction in two treatment groups from baseline to 12 weeks was the main outcome measure. Results Mean diurnal IOP was similar at baseline for both groups. Mean reduction in IOP from baseline to 12 weeks was 9.92 mm Hg (p = 0.001) in group 1 and 9.22 (p = 0.001) in group 2. The reduction in IOP in both groups 1 and 2 was statistically significant at all time intervals. There was a statistically significant advantage for group 1 at 12 weeks for both time readings (p = 0.013 and 0.002 respectively) as compared to group 2. Conclusion The fixed combination of latanoprost and timolol was more effective than that of dorzolamide and timolol in reducing mean diurnal IOP and both treatments were well tolerated. To confirm further such studies are required. How to cite this article Ratol S, Walia R, Chaudhry M. A Comparative Analysis of the Efficacy and Safety of fixed Combinations of Latanoprost/Timolol vs Dorzolamide/Timolol in Primary Open Angle Glaucoma or Ocular Hypertension. J Postgrad Med Edu Res 2012;46(4):172-176.

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Preservative-free versus preserved latanoprost eye drops for reducing intraocular pressure: a non-inferiority phase III randomized, multi-center, single-blind, parallel-group controlled trial

Medical hypothesis discovery and innovation in ophthalmology ◽

10.51329/mehdiophthal1413 ◽

2021 ◽

Vol 9 (4) ◽

Author(s):

Panos Theodosiadis ◽

Anastasios Konstas ◽

Ioannis Halkiadakis ◽

Vasiliki Dimera ◽

Dimitrios Koufakis ◽

...

Keyword(s):

Intraocular Pressure ◽

Ocular Hypertension ◽

Open Angle Glaucoma ◽

Ophthalmic Solution ◽

Phase Iii ◽

Point Estimate ◽

Eye Drops ◽

Open Angle ◽

Parallel Group ◽

Preservative Free

Background: The aim of this study was to test the non-inferiority of preservative-free (PF) latanoprost 50 μg/mL multi-dose ophthalmic solution versus the marketed benzalkonium chloride (BAK)-preserved latanoprost 50 μg/mL ophthalmic solution in patients with open-angle glaucoma and patients with ocular hypertension. Methods: This was a prospective, national, randomized, multi-center, observer-blind, parallel-group controlled clinical trial. Patients were randomized to receive either PF or BAK-preserved latanoprost once daily for 12 weeks. The primary endpoint was the change in intraocular pressure (IOP) at 8:00 AM in the affected eye between the end of the treatment (week 12) and the baseline (week 0). Secondary measurements were taken at weeks 2 and 6, with IOP being recorded at 8:00 AM, 12:00 PM, and 4:00 PM. Results: A total of 158 patients were included in the per protocol (PP) population (77 in the PF latanoprost treatment arm and 81 patients in the BAK-preserved latanoprost treatment arm). PF latanoprost was non-inferior to BAK-preserved latanoprost in reducing IOP at 8:00 AM in the study eye from the baseline (week 0) to the end of the treatment (week 12). The point estimate of the between-treatment difference was 0.1 mmHg (95% confidence interval: -0.646, 0.847). Mean between-group differences in IOP reduction from the baseline to each of the secondary measurements were also similar between the two treatment arms. The two treatments were well tolerated and had comparable adverse event profiles. Conclusions: PF latanoprost was non-inferior to BAK-preserved latanoprost in reducing IOP in patients with open-angle glaucoma or ocular hypertension. Both treatments were well tolerated.

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