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Comparision of efficacy and safety of Fixed Drug Combination of Timolol with two different molecules:Brinzolamide and Brimonidine

Comparative study for efficacy and safety of fixed drug combination between Timolol Maleate(0.5 percent) plus Brinzolamide(1 percent) and Timolol Maleate (0.5 percent) plus Brimonidine Tartrate(0.2 percent) in Primary Open Angle Glaucoma - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/09/094026
Enrollment
140
Registered
2025-09-01
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H401- Open-angle glaucoma

Interventions

Intervention1: Timolol Maleate plus Brinzolamide Tartrate: Timolol Maleate (0.5%) plus Brinzolamide (1%) eye drops Intervention2: Timolol Maleate plus Brinzolamide: Timolol Maleate (0.5%) plus Brinzol

Sponsors

GCS medical college hospital and research centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Freshly diagnosed primary open angle glaucoma patients 2.Intraocular pressure more than or equal to 21mmHg 3.Patients already being treated with study drug 4.Age more than 20 years

Exclusion criteria

Exclusion criteria: 1.Patients on or requiring systemic or topical anti-glaucoma medications other than these two Fixed Drug Combinations 2.Patients with Best Corrected Visual Acuity less than 6/60 3.Patients with Secondary open angle glaucoma 4.Cataract surgery within 3 months of study 5.Pre-existing macular and retinal pathologies,ocular surgery,ocular trauma 6.Known allery to Sulfa group 7.History of hypersensitivity to any of the study medication or their products 8.Contact lens users 9.Pregnant women

Design outcomes

Secondary

MeasureTime frame
To compare compliance of both Fixed Drug CombinationTimepoint: baseline , 2nd week,1 month,3 months & 6 months

Primary

MeasureTime frame
Efficacy: -IOP reduction in mmHg -Optic disc changes -Visual field changes -RNFL by OCT Safety -tolerability/adverse reactions -Side effectsTimepoint: Evaluation at baseline (0) visit, follow up at 2nd week,1 month,3 months and 6 months for efficacy and safety

Countries

India

Contacts

Public ContactKhushi Macwan

GCS Medical College,Hospital and Research Centre

drruchis@yahoo.co.in9327456667

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026