An Eight-week, Multicentric, Randomized, Interventional, Open-label, Phase 4, Parallel Comparison of the Efficacy and Tolerability of the Fixed Combination of Timolol Maleate 0.5%/Brimonidine Tartrate 0.2% Versus Fixed Combination of Timolol Maleate 0.5%/Dorzolamide 2% in Patients With Elevated Intraocular Pressure

Purpose: To analyze the efficacy and safety of preservative-containing and preservative-free 0.2% brimonidine tartrate and 0.5% timolol maleate fixed combination drug in normal tension glaucoma.Methods: Fifty-one patients (84 eyes) who were diagnosed with normal tension glaucoma and with preservative-containing or preservative-free brimonidine-timolol fixed combinations alone were analyzed retrospectively from January 2017 to February 2020. Intraocular pressure (IOP) was measured four times a day (9 a.m., 11 a.m., 2 p.m., and 4 p.m.) before and at 6 months after applying eye drops. We analyzed and compared the effect of lowering IOP and the occurrence of intra or extra-ocular adverse effects.Results: A significant mean IOP reduction was shown in both groups: -1.95 ± 2.50 mmHg (-12.26 ± 15.87%) in the preservative-containing group and -1.60 ± 2.06 mmHg (-10.54 ± 13.94%) in the preservative-free group at 6 months after eyedrop instillation. The IOP was lowest in both groups at 11 a.m. There were no significant differences between the two groups in lowering IOP. Serious adverse effects causing discontinuation of the eye drops were not observed.Conclusions: Both preservative-containing and preservative-free brimonidine-timolol fixed combinations are effective in lowering IOP in normal tension glaucoma patients and are considered to be effective as eye drops without serious adverse effects.

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Fixed Combination of Travoprost and Timolol Maleate Reduces Intraocular Pressure in Japanese Patients with Primary Open-Angle Glaucoma or Ocular Hypertension: A Prospective Multicenter Open-Label Study

Advances in Therapy ◽

10.1007/s12325-015-0246-9 ◽

2015 ◽

Vol 32 (9) ◽

pp. 823-837 ◽

Cited By ~ 4

Author(s):

Tadashi Nakano ◽

Shiro Mizoue ◽

Nobuo Fuse ◽

Aiko Iwase ◽

Shun Matsumoto ◽

...

Keyword(s):

Intraocular Pressure ◽

Primary Open Angle Glaucoma ◽

Fixed Combination ◽

Open Angle Glaucoma ◽

Japanese Patients ◽

Open Angle ◽

Timolol Maleate ◽

Open Label ◽

Open Label Study ◽

Label Study

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Intraocular pressure reduction of fixed combination timolol maleate 0.5% and dorzolamide 2% (Cosopt) administered three times a day

Clinical Ophthalmology ◽

10.2147/opth.s30321 ◽

2012 ◽

pp. 283

Author(s):

Elad Moisseiev ◽

Shemesh ◽

Lazar ◽

Kurtz

Keyword(s):

Intraocular Pressure ◽

Fixed Combination ◽

Pressure Reduction ◽

Timolol Maleate ◽

Intraocular Pressure Reduction

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Comparative efficacy study of brimonidine tartrate 0.15% and timolol maleate 0.5% ophthalmic solution (benzalkonium chloride free) versus Brimolol® (with benzalkonium chloride) following single ocular instillation in New Zealand white rabbits

International Journal of Basic & Clinical Pharmacology ◽

10.18203/2319-2003.ijbcp20202939 ◽

2020 ◽

Vol 9 (7) ◽

pp. 1050

Author(s):

Amit Thavkar ◽

Sateesh Kumar Chauhan ◽

Subhas Bhowmick ◽

Vinod Burade

Keyword(s):

Intraocular Pressure ◽

New Zealand ◽

Repeated Measures ◽

Benzalkonium Chloride ◽

Ophthalmic Solution ◽

Eye Drops ◽

Timolol Maleate ◽

Repeated Measures Analysis ◽

Brimonidine Tartrate ◽

Ophthalmic Solutions

Background: Benzalkonium chloride (BKC) is the most used preservative in topical eye drops but it causes effects such as dry eye and trabecular meshwork degeneration. Polyhexamethylene biguanide (PHMB) is a polymeric biguanide is a less harmful preservative used in ophthalmic solutions. The objective of this study to com-pare the efficacy of PHMB preserved versus BKC preserved ophthalmic solutions containing brimonidine tartrate and timolol maleate on intraocular pressure (IOP) following single ocular instillation in New Zealand white (NZW) rabbits.Methods: This study was conducted on 12 normotensive male NZW rabbits (2.9-3.6 kg) between 6-9 months of age. Animals received single ocular instillation of 35 µl ophthalmic solution containing brimonidine tartrate 0.15 %w/v and timolol maleate 0.5% w/v with PHMB as preservative (n=6, test) or BKC as preservative (n=6, reference) as per the randomization. Intraocular pressure (IOP) was measured before and 2, 4, 6, 8 and 24 hours after instillation using a pneumatonometer. Percentage change in IOP from pre-instillation values were calculated. Changes in IOP were analysed using the repeated-measures analysis of variance followed by Bonferroni post-test.Results: Single ocular instillation of PHMB and BKC formulations show significant IOP reduction up to 6 hours as compared with baseline (p<0.05). Reduction in IOP was 35.8% and 32.0% at 2 hours with PHMB and BKC formulations respectively. No differences were observed between the test and reference groups for change in IOP from baseline.Conclusions: PHMB preserved brimonidine tartrate 0.15% w/v and timolol maleate 0.5% w/v ophthalmic solution was comparable to BKC preserved solution in normotensive NZW rabbits.

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Selective Laser Trabeculoplasty Versus Brimonidine Tartrate 0.2%/Timolol Maleate 0.5% As Adjunct Therapy in Primary Open Angle Glaucoma: A Randomized Prospective Trial

10.21203/rs.3.rs-20350/v1 ◽

2020 ◽

Author(s):

Ian McWherter ◽

Meredith Lanham ◽

Lee Peplinski ◽

Nikolaos Zagorianos ◽

Andrew Steele ◽

...

Keyword(s):

Intraocular Pressure ◽

Primary Open Angle Glaucoma ◽

Open Angle Glaucoma ◽

Complication Rates ◽

Open Angle ◽

Selective Laser Trabeculoplasty ◽

Timolol Maleate ◽

Adjunct Therapy ◽

Laser Trabeculoplasty ◽

Brimonidine Tartrate

Abstract Purpose: To compare the intraocular pressure lowering efficacy of selective laser trabeculoplasty to brimonidine tartrate 0.2%/timolol maleate 0.5% in patients with uncontrolled primary open-angle glaucoma on a prostaglandin analog alone. A secondary outcome was to evaluate the complication rates of selective laser trabeculoplasty.Patients and Methods: Twenty-three patients were randomized to two treatment groups within this prospective, observer-masked single site, all optometrist, pilot study. Group 1 (N=12) received 360 degrees of selective laser trabeculoplasty as additional treatment while Group 2 (N=11) was started on FCBT. Outcomes of both groups were measured at eight weeks.Results: Both treatment regimens were found to be statistically significant in lowering IOP when used as adjunct therapy. The average IOP reduction for Group 1 and Group 2 was 28.4% (SD = .17) and 28.2% (SD = .12) respectively. The incidence of an intraocular pressure spike following SLT in this patient population was found to be 8.3%. No major complications were observed in this study.Conclusion: Selective laser trabeculoplasty and brimonidine tartrate 0.2%/timolol maleate 0.5% were shown to be equivalent in lowering intraocular pressure in uncontrolled primary open angle glaucoma patients when used as adjunct therapy for patients on a prostaglandin analog. Additionally, this is the first prospective study of optometrists performing selective laser trabeculoplasty. Although this study had a small sample size, the results appeared to show that efficacy and complication rates were comparable to previously published data; however, these results need to be confirmed with a larger multi-centered trial.Trial Registration: ISRCTN Study ID ISRCTN30070325, retrospectively registered 12/14/2018. http://www.isrctn.com/ISRCTN30070325.

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