Health Condition 1: H542- Low vision, both eyes Health Condition 2: H545- Low vision, one eye
Conditions
Interventions
Intervention1: FDC of Ripasudil and Timolol: FDC of Ripasudil plus Timolol Eye Drops -
One drop instilled in affected eye twice daily for 84�±2 days Route of administartion - Topical
Control Interv
Sponsors
Ajanta Pharma Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean reduction in the IOP from baseline to end of study visit at 9.00 AM Ã?± 1 hour 11.00 AM Ã?± 1 hour and 5.00 PM Ã?± 1 hourTimepoint: Mean reduction in the IOP from baseline to end of study visit at 9.00 AM Ã?± 1 hour 11.00 AM Ã?± 1 hour and 5.00 PM Ã?± 1 hour | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean reduction in the IOP from baseline to day 28Ã?±2 Mean reduction in the IOP from baseline to day 56 Timepoint: 09:00 AM, 11:00 AM and 05 PM | — |
Countries
India
Contacts
Public ContactDr Piyush Jain
ASG Eye Hospital
Outcome results
None listed