A clinical Trial in patients suffering from open angle glaucoma or ocular hypertension. This clinical trial is to study effect, safety and tolerability of Brinzolamide + Timolol Ophthalmic Suspension (test product) in comparison to Dorzolamide plus Timolol Maleate (reference product)eye drops.
- Conditions
- Health Condition 1: null- Open angle glaucoma or ocular hypertensionHealth Condition 2: H401- Open-angle glaucoma
- Registration Number
- CTRI/2012/04/002609
- Lead Sponsor
- Ajanta Pharma Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 200
1.Male and Female patients of age 18 years and older.
2.Patient having clinical diagnosis of ocular hypertension.
3.Availability of subjects for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent.
1.Male and Female patients of age less than 18 years.
2.A history of hypersensitivity to brinzolamide and other sulphonamides, timolol, or any other component of the medication.
3.Patients suffering from bronchial asthma, a history of bronchial asthma, or severe chronic obstructive pulmonary disease.
4.Patients suffering from sinus bradycardia, second or third degree atrioventricular block, overt cardiac failure, or cardiogenic shock.
5.Patients suffering from severe allergic rhinitis and bronchial hyperreactivity.
6.Patients suffering from severe renal impairment (see Hepatic / Renal Impairment).
7.Patients who have participated in other clinical studies within 3 months.
8.Any condition which are likely to hinder the compliance with the protocol.
9.Patients should not take other topical or oral beta-blockers during the study period.
10.Patients with broken rear lens capsule or anterior eye lenses or in patients with known risk factors for cystoid macular edema or iritis / uveitis.
11.Eye surgery or laser treatment within 12 weeks prior to study enrollment.
12.Patients who are scheduled to undergo surgery of the opposite eye during the study period.
13.Patients who are required to wear contact lens during the study period.
14.Significant visual field loss or evidence of progressive visual field loss within the last year.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method