Clinical Study to Evaluate Safety, tolerability and efficacy of FDC of Timolol 0.5%, Brimonidine 0.2% and Brinzolamide 1% eye drops in patients with Glaucoma

An Open-label, Prospective, Non-comparative, Multicentric, Real world, Active Post-Marketing Surveillance Study of FDC of Timolol 0.5%, Brimonidine 0.2% and Brinzolamide 1% eye drops in patients with Open-angle glaucoma or ocular hypertension not responding adequately to dual drug therapy - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2026/04/109312

Enrollment

212

Registered

2026-04-24

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-27

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: FDC of Timolol 0.5%, Brimonidine 0.2% and Brinzolamide 1% eye drops.: Instill one drop twice daily in the affected eye(s) around the same time for 12 weeks Control Intervention1: NIL: N

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male or female subjects aged above 18 years who are on dual drug therapy with progressive primary open-angle glaucoma (including pseudo exfoliation or pigment dispersion) or ocular hypertension in at least one eye confirmed by Goldmann applanation tonometry. 2. Subject with known cases of glaucoma and target not achieved with dual drug as per the guidelines. 3. Subjects with the ability to understand and provide a written informed consent form, which must have been obtained prior to screening. 4. Subjects willing to comply with the protocol requirements.

Exclusion criteria

Exclusion criteria: 1. Subjects with known hypersensitivity to any of the components of the formulation. 2. Subjects who are blind or subjects who have a single eye. 3. Subjects who are scheduled to undergo surgery of the eye during the study period. 4. History of chronic, recurrent or severe inflammatory eye disease 5. History of ocular trauma or any other intraocular surgery within the past 6 months in either eye. 6. Pregnancy and lactation: 7. Trial related conditions: Concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent. Suspected inability or unwillingness to comply with the study procedures. 8. Any other conditions which would make the patient, in the opinion of the Investigator, unsuitable for the study.

Design outcomes

Primary

Measure	Time frame
The assessment of the safety of Subjects [comparison of the incidence of treatment-emergent adverse event (TEAE)] and change in ophthalmological [Visual Acuity (VA), Slit Lamp Biomicroscopy] parameters.Timepoint: Week 2, Week 6 and Week 12	—

Secondary

Measure	Time frame
Mean reduction in IOP from baselineTimepoint: Week 6;Mean reduction in the IOP from baseline to end of study visitTimepoint: Week 12	—

Countries

India

Contacts

Public ContactDr Krishna Kumar M

Mediclin Clinical Research

ravindra.mote@mediclincr.com8888884024

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026