A Clinical Study to evaluate the efficacy, safety and tolerability of triple fixed dose combination of Timolol 0.5% Brimonidine 0.2% Brinzolamide 1% eye drops in patients with Open angle glaucoma or ocular hypertension not responding to dual drug therapy

An Open Label, Multicentric, Phase III, Prospective study to evaluate the efficacy, safety and tolerability of triple fixed dose combination of Timolol 0.5% Brimonidine 0.2% Brinzolamide 1% eye drops in patients with Open angle glaucoma or ocular hypertension not responding to dual drug therapy - NA

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/03/031676

Enrollment

210

Registered

2021-03-03

Start date

Unknown

Completion date

Unknown

Last updated

2023-01-09

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: Triple fixed dose combination of Timolol 0.5%, Brimonidine 0.2%, Brinzolamide 1% eye drops one drop twice a day for 12 weeks: Eye drops to be administered twice a day (at 8 AM and 8 PM

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subjects >=18 years of age of both gender 2. Diagnosed with unilateral or bilateral open angle glaucoma (including pseudo exfoliation or pigment dispersion) or ocular hypertension 3. Subjects who are already on dual drug therapy on any two of the following anti-glaucoma drugs, Timolol (0.5%), Brimonidine (0.1% or 0.2%), Brinzolamide (1%) /Dorzolamide (2%) eye drops with IOP of 22-32 mmHg in at least one eye 4. Best Corrected Visual Acuity (BCVA) of 6/24 or better in study eye(s) 5. Gonioscopy angle of >=2 in the study eye (s) 6. In case of women, postmenopausal ( >12 months without menstrual bleeding), surgically sterilized, or on use of effective birth control measures 7. Willing to complete all study-related procedures 8. Ability to understand and the willingness to sign and date a written informed consent document at the screening visit before any protocol specific procedures are performed.

Exclusion criteria

Exclusion criteria: 1. Women of childbearing potential if pregnant (test positive for pregnancy) at screening visit, breastfeeding, or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study. 2. Clinically significant or progressive retinal disease (i.e. retinal degeneration, diabetic retinopathy, retinal detachment or retinal tears) or optic nerve disease. 3. Ocular laser surgery within the 3 months prior to entry. 4. Any abnormality preventing reliable applanation tonometry. 5. Any other conditions which would make the patient, in the opinion of the Investigator, unsuitable for the study. 6. Recent use of high-dose ( >1 gram daily) salicylate therapy. 7. Subject with known allergy or hypersensitivity to the components of the formulation 8. Participation in another clinical trial within past 30 days 9. Other protocol-specified exclusion criteria may apply

Design outcomes

Primary

Measure	Time frame
Change from Baseline in Intraocular Pressure (IOP)Timepoint: Baseline to Week 12	—

Secondary

Measure	Time frame
Change from baseline in the mean IOP at week 2 and week 6Timepoint: Baseline to week 2, week 6	—

Countries

India

Contacts

Public ContactDr Krishna Kumar M

Micro Labs Limited

drmanjula@microlabs.in08022370451

Outcome results

None listed

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