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
- Conditions
- Health Condition 1: null- Ocular Hypertension Or Open-Angle Glaucoma
- Registration Number
- CTRI/2014/09/005062
- Lead Sponsor
- Sun Pharmaceutical Industries Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of change in IOP will be carried out as below. <br/ ><br>Change in 2-hour IOP at the end of treatment as compared to baseline visit. <br/ ><br>Change in 0-hour IOP at the end of treatment as compared to baseline visit. <br/ ><br>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 Outcome Measures
Name Time Method Evaluation of global impression by patients and investigatorsTimepoint: At Day 84 end of study.