A clinical trail to reduce elevated Intraocular Pressure (IOP) in adult participants with Open Angle Glaucoma or Ocular Hypertension to evaluate the Safety, Tolerability and Efficacy of of Brinzolamide Brimonidine Tartrate and Timolol Ophthalmic Suspension

A Multicentric, Open-label, Prospective Non-comparative Active Post Marketing Surveillance Study to evaluate the Safety Tolerability and Efficacy of Fixed Dose Combination of Brinzolamide 10 mg, Brimonidine Tartrate 2 mg and Timolol 5 mg Ophthalmic Suspension to reduce elevated Intraocular Pressure (IOP) in adult participants with Open Angle Glaucoma or Ocular Hypertension for whom monotherapy or dual therapy provides insufficient IOP reduction - NIL

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/11/097648

Enrollment

230

Registered

2025-11-18

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-02

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: Fixed Dose Combination of Brinzolamide 10 mg, Brimonidine Tartrate 2 mg and Timolol 5 mg Ophthalmic Suspension: One drop of fixed dose combination of Brinzolamide 10 mg, Brimonidine Tar

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adult male and female participants more 18 to less then 75 years of age. 2. Diagnosed with unilateral or bilateral open angle glaucoma (including pseudo exfoliation or pigment dispersion) or ocular hypertension. 3. Participants who are already on monotherapy or dual drug therapy on any of the following anti-glaucoma drugs, Timolol (0.5 percent), Brimonidine (0.1 or 0.2 percent), Brinzolamide (1 percent) or Dorzolamide (2 percent) eye drops with IOP of 22-32 mmHg in at least one eye. 4. Best Corrected Visual Acuity (BCVA) of 6 by 24 or better in study eye(s). 5. Gonioscopy angle more then grade 2 on Shaffer grading in the study eye(s). 6. Participants who are willing to give informed consent for participation in the study and willing to adhere to all protocol procedures.

Exclusion criteria

Exclusion criteria: 1. Participants with a known history of hypersensitivity to the study medications or any of the ingredients of the formulation. 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 3 months prior to entry. 4. Any intraocular surgery (e.g, cataract surgery) within 6 months prior to entry. 5. Corneal abnormalities that could preclude accurate IOP readings with tonometry.

Design outcomes

Primary

Measure	Time frame
1. The assessment of the safety of participants [Based on the incidence of treatment-emergent adverse event (TEAE)]. 2. The assessment of the tolerability of the study drug will be based on the incidence of AEs and SAEs.Timepoint: 12 weeks	—

Secondary

Measure	Time frame
1. Change from baseline in the mean IOP at Visit 3/Week 2/Day 14 2, Visit 4/Week 6/Day 42 2 and Visit 5/Week 12/Day 84 2.Timepoint: 12 weeks	—

Countries

India

Contacts

Public ContactDr Neeta Nargundkar

Biosphere Clinical Research Pvt Ltd

drneeta@biospherecro.com9029025200

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026