A clinical trial to study the efficacy and safety of Fixed dose combination of Brinzolamide and Timolol versus Fixed dose combination of Dorzolamide and Timolol in patients with ocular hypertension or open angle glaucoma

EVALUATION OF EFFICACY AND SAFETY OF TWO FIXED DOSE COMBINATION OF CARBONIC ANHYDRASE INHIBITOR AND BETA BLOCKER FOR THE TREATMENT OF ELEVATED INTRAOCULAR PRESSURE IN PATIENTS WITH OCULAR HYPERTENSION OR OPEN-ANGLE GLAUCOMA: A RANDOMIZED, OPEN LABEL, COMPARATIVE, MULTICENTRIC STUDY

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2014/09/005062

Enrollment

200

Registered

2014-09-25

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Ocular Hypertension Or Open-Angle Glaucoma

Interventions

Intervention1: Brinzolamide and Timolol Ophthalmic Suspension: FDC Brinzolamide 10 mg/mL + timolol 5mg/mL eye drops, suspension. The recommended dose is one drop two times in a day for entire study du

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male/Female patients aged between 18-75 years. 2. Patients diagnosed with Primary Openâ??angle glaucoma. 3. Patients with IOP of 24-36 mm Hg of affected eye(s). 4. New Patients or Patients who are on mono-therapy of either CAIs or Beta-blockers or any other IOP-lowering therapy not adequately controlled. 5. Patients who have given their informed consent.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women and women of childbearing potential who are not using contraceptives. 2. Patients with a history of allergic hypersensitivity to oral or topical CAIs, Beta-blockers, sulfonamide drugs, or any components of these medications. 3. Patients with acute or chronic conjunctivitis. 4. Patients with uncontrolled hypertension, dry eye syndrome, diabetic retinopathy, hyperchloraemic acidosis and insulin dependent diabetes. 5. Patients undergone intraocular surgery or laser surgery within the past 3 months. 6. Patients currently using any systemic corticosteroid, or is having had therapy with any investigational agent within past 30 days. 7. Patients with severe, unstable, or uncontrolled cardiovascular or pulmonary disease. 8. Patients with history of hematologic disorders other than mild anemia. 9. History of non-compliance to medical regimens or those patients unwilling to comply with the study protocol.

Design outcomes

Primary

Measure	Time frame
Evaluation of change in IOP will be carried out as below. Change in 2-hour IOP at the end of treatment as compared to baseline visit. Change in 0-hour IOP at the end of treatment as compared to baseline visit. Timepoint: Assessment will be done on baseline (first day of medication), at the end of 4th week, at end of 8th week and at end of 12th week.	—

Secondary

Measure	Time frame
Evaluation of global impression by patients and investigatorsTimepoint: At Day 84 end of study.	—

Countries

India

Contacts

Public ContactMr Guruprasad Palekar

Sun Pharmaceutical Industries Limited

bhaumik.mody@sunpharma.com91-9820590463

Outcome results

None listed

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