A Clinical Study to evaluate the efficacy, safety and tolerability of triple fixed dose combination of Timolol 0.5% Brimonidine 0.2% Brinzolamide 1% eye drops in patients with Open angle glaucoma or ocular hypertension not responding to dual drug therapy
- Conditions
- Health Condition 1: H401- Open-angle glaucoma
- Registration Number
- CTRI/2021/03/031676
- Lead Sponsor
- Micro Labs Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 210
1.Subjects >=18 years of age of both gender
2.Diagnosed with unilateral or bilateral open angle glaucoma (including pseudo exfoliation or pigment dispersion) or ocular hypertension
3.Subjects who are already on dual drug therapy on any two of the following anti-glaucoma drugs, Timolol (0.5%), Brimonidine (0.1% or 0.2%), Brinzolamide (1%) /Dorzolamide (2%) eye drops with IOP of 22-32 mmHg in at least one eye
4.Best Corrected Visual Acuity (BCVA) of 6/24 or better in study eye(s)
5.Gonioscopy angle of >=2 in the study eye (s)
6.In case of women, postmenopausal ( >12 months without menstrual bleeding), surgically sterilized, or on use of effective birth control measures
7.Willing to complete all study-related procedures
8.Ability to understand and the willingness to sign and date a written informed consent document at the screening visit before any protocol specific procedures are performed.
1.Women of childbearing potential if pregnant (test positive for pregnancy) at screening visit, breastfeeding, or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study.
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 the 3 months prior to entry.
4.Any abnormality preventing reliable applanation tonometry.
5.Any other conditions which would make the patient, in the opinion of the Investigator, unsuitable for the study.
6.Recent use of high-dose ( >1 gram daily) salicylate therapy.
7.Subject with known allergy or hypersensitivity to the components of the formulation
8.Participation in another clinical trial within past 30 days
9.Other protocol-specified exclusion criteria may apply
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from Baseline in Intraocular Pressure (IOP)Timepoint: Baseline to Week 12
- Secondary Outcome Measures
Name Time Method Change from baseline in the mean IOP at week 2 and week 6Timepoint: Baseline to week 2, week 6