A clinical study to evaluate efficacy, safety and tolerability of Ripasudil 0.4% plus Timolol Maleate 0.5% vs Ripasudil 0.4% and Timolol Maleate 0.5% monotherapy for the treatment of open angle glaucoma
- Conditions
- Health Condition 1: H542- Low vision, both eyesHealth Condition 2: H545- Low vision, one eye
- Registration Number
- CTRI/2022/01/039211
- Lead Sponsor
- Ajanta Pharma Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Newly diagnosed Male or female subjects aged greater than equal 18 and less than equal 65 years with primary open angle glaucoma or ocular hypertension in at least one eye confirmed by Goldmann applanation tonometry
Subjects with IOP between 22 mmHg to 36 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
Best corrected visual acuity 6 by 60 or better
Subjects with ability to understand and provide written informed consent form which must have been obtained prior to screening
Subjects willing to comply with the protocol requirements
Subjects with known hypersensitivity to any of the components of the formulation
Has clinical laboratory evaluations including biochemistry and hematology are not within the reference range for the testing laboratory and the results are deemed clinically significant by the investigator
Subjects with known case of any severe or advanced cases of Glaucoma IOP greater than 36 mmHg in either eye
Shaffer angle grade less than 2 in either eye range 0 complete or partial closure to 3 wide open angle greater than 20 as measured by Gonioscopy
Subjects who are blind or subjects who have a single eye
Severe central visual field loss in either eye measured by Perimetry
Subjects having central corneal thickness greater than 620 �µm in either eye as measured by Pachymetry
Cupdisc ratio greater than 0.80
Subject who are schedule to undergo surgery of the eye during the study period
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean reduction in the IOP from baseline to end of study visit at 9.00 AM �± 1 hour 11.00 AM �± 1 hour and 5.00 PM �± 1 hourTimepoint: Mean reduction in the IOP from baseline to end of study visit at 9.00 AM �± 1 hour 11.00 AM �± 1 hour and 5.00 PM �± 1 hour
- Secondary Outcome Measures
Name Time Method Mean reduction in the IOP from baseline to day 28�±2 <br/ ><br> <br/ ><br>Mean reduction in the IOP from baseline to day 56 <br/ ><br>Timepoint: 09:00 AM, 11:00 AM and 05 PM