The Efficacy and Safety of Preservative-containing and Preservative-free Brimonidine-Timolol Fixed Combination in Normal Tension Glaucoma

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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Efficacy and safety of fixed-combination brimonidine tartrate/timolol maleate in primary open-angle glaucoma, including normal-tension glaucoma

Japanese Journal of Ophthalmology ◽

10.1007/s10384-020-00796-3 ◽

2021 ◽

Vol 65 (2) ◽

pp. 295-305

Author(s):

Sang Woo Park ◽

Joon Mo Kim ◽

Ji Woong Lee ◽

Joy Maglambayan ◽

Susan Simonyi ◽

...

Keyword(s):

Primary Open Angle Glaucoma ◽

Fixed Combination ◽

Open Angle Glaucoma ◽

Normal Tension Glaucoma ◽

Open Angle ◽

Efficacy And Safety ◽

Timolol Maleate ◽

Brimonidine Tartrate

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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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Intraocular pressure reduction using a fixed combination of timolol maleate 0.5% and brimonidine tartrate 0.2% administered three times daily

Clinical Ophthalmology ◽

10.2147/opth.s47760 ◽

2013 ◽

pp. 1269 ◽

Cited By ~ 4

Author(s):

Elad Moisseiev ◽

Kurtz ◽

Lazar ◽

Shemesh

Keyword(s):

Intraocular Pressure ◽

Fixed Combination ◽

Pressure Reduction ◽

Timolol Maleate ◽

Intraocular Pressure Reduction ◽

Brimonidine Tartrate

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Efficacy and safety of preoperative IOP reduction using a preservative-free fixed combination of dorzolamide/timolol eye drops versus oral acetazolamide and dexamethasone eye drops and assessment of the clinical outcome of trabeculectomy in glaucoma

PLoS ONE ◽

10.1371/journal.pone.0171636 ◽

2017 ◽

Vol 12 (2) ◽

pp. e0171636 ◽

Cited By ~ 6

Author(s):

Katrin Lorenz ◽

Joanna Wasielica-Poslednik ◽

Katharina Bell ◽

Giulia Renieri ◽

Alexander Keicher ◽

...

Keyword(s):

Clinical Outcome ◽

Fixed Combination ◽

Eye Drops ◽

Efficacy And Safety ◽

Preservative Free

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Safety and Efficacy of Fixed Combination Travoprost-Timolol in the Lowering of Intraocular Pressure

Clinical Medicine Insights Therapeutics ◽

10.4137/cmt.s2030 ◽

2010 ◽

Vol 2 ◽

pp. CMT.S2030

Author(s):

Robert J. Noecker ◽

Michael J. Pokabla

Keyword(s):

Intraocular Pressure ◽

Fixed Combination ◽

Patient Adherence ◽

Open Angle Glaucoma ◽

Efficacy And Safety ◽

Timolol Maleate ◽

Potential Cost ◽

Once Daily ◽

Safety And Efficacy ◽

Online Resource

The fixed combination eye drop Duotrav is a combination of travoprost 0.004% and timolol maleate 0.5%. Both travoprost and timolol have been used separately for the treatment of glaucoma by lowering intraocular pressure. Multiple studies have demonstrated the efficacy and safety of the fixed combination travoprost/timolol for the treatment of open-angle glaucoma and ocular hypertension. The once daily dosing of this combination offers multiple potential advantages such as patient adherence, potential cost advantages, and reduction in exposure to preservatives. This article discusses the benefits of fixed combination medications and summarizes past and recent studies listed on the online resource PubMed of the fixed combination travoprost/timolol with comparison to both monotherapy and other similar fixed combination ocular hypotensive preparations.

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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

Journal of Glaucoma ◽

10.1097/ijg.0b013e318168f008 ◽

2008 ◽

Vol 17 (8) ◽

pp. 674-679 ◽

Cited By ~ 19

Author(s):

Marcelo Hatanaka ◽

Daniel E. Grigera ◽

Wilma L. Barbosa ◽

Marcelo Jordao ◽

Remo Susanna

Keyword(s):

Intraocular Pressure ◽

Fixed Combination ◽

Timolol Maleate ◽

Open Label ◽

Elevated Intraocular Pressure ◽

Open Label Phase ◽

Brimonidine Tartrate

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Fixed combinations of glaucoma medications

Srpski arhiv za celokupno lekarstvo ◽

10.2298/sarh1510626b ◽

2015 ◽

Vol 143 (9-10) ◽

pp. 626-631 ◽

Cited By ~ 2

Author(s):

Nikola Babic

Keyword(s):

Intraocular Pressure ◽

Fixed Combination ◽

Pressure Control ◽

Line Treatment ◽

Efficacy And Safety ◽

First Line ◽

Advantages And Disadvantages ◽

Role Efficacy ◽

Indications For Use ◽

First Line Treatment

The first line treatment in the management of glaucoma is topical medical therapy. Many patients with glaucoma require multiple medications for adequate intraocular pressure control. For patients who need multi-dose regimens to control intraocular pressure, fixed combinations offer convenience, efficacy and safety. This review summarizes the role, efficacy, mechanism of action and indications for use of modern fixed combination of topical glaucoma medications. The review shows the advantages and disadvantages of a prescribing fixed combination in daily clinical practice.

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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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