CTRI/2020/01/022619
Completed
Phase 3
A Comparative, Randomized, Two Arm, Double Blind, Parallel Group, Multicentric, Phase III Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Netarsudil Ophthalmic Solution 0.02% w/v Versus Timolol Maleate Eye Drops 0.5% w/v in treatment of elevated intraocular pressure (IOP) in subjects with open angle glaucoma or ocular hypertension.
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: H401- Open-angle glaucoma
- Sponsor
- Ajanta Pharma Ltd
- Enrollment
- 197
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects meeting all of the following criteria will be recruited for the trial
- •1\.Male and Female subjects between 18 â?? 65 years of age (both inclusive).
- •2\.Newly diagnosed patients of primary open angle glaucoma / ocular hypertension in at least one eye confirmed by Goldmann applanation tonometry.
- •3\.Subjects with IOP between 22 mmHg â?? 27 mmHg at the time of screening in any one eye. In case both the eyes of a single subject are affected then the eye fulfilling the criteria will be considered for the evaluations. If both eyes are fulfilling the criteria, then the right eye will be considered for the study.
- •4\.Visual acuity 6/60 or better.
- •5\.Voluntary willingness of patient to give written informed consent prior to participation in trial.
Exclusion Criteria
- •Subjects will be excluded if ANY of the following conditions apply:
- •Ophthalmic:
- •1\.Subjects with any severe or advanced cases of Glaucoma
- •2\.Shaffer angle grade \<\= 2 in either eye, as measured by Gonioscopy
- •3\.Subjects with pseudoexfoliation or pigment dispersion component glaucoma
- •4\.Subjects who are blind or subjects who have a single eye.
- •5\.Severe central visual field loss in either eye measured by Perimetry
- •6\.Cup/disc ratio greater than 0\.80
- •7\.Current or history within three months prior to baseline of significant ocular disease, e.g., corneal edema, uveitis, ocular infection, or ocular trauma in either eye.
- •8\.Current corneal abnormalities that would prevent accurate IOP readings with the Goldmann applanation tonometer.
Outcomes
Primary Outcomes
Not specified
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