To find out Ripasudil is safe and efficient drug than Timolol in Primary Open Angle Glaucoma
Phase 3
Completed
- Conditions
- Health Condition 1: H401- Open-angle glaucoma
- Registration Number
- CTRI/2021/07/035000
- Lead Sponsor
- Pt B D Sharma PGIMS Rohtak
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
1. Patients above 18 years of age
2. Patients newly diagnosed as having Primary Open Angle Glaucoma
3. Patients eligible if the best corrected visual acuity is 6/60 or better and visual field showing glaucomatous changes.
4. Patients willing to give retained informed consent.
Exclusion Criteria
1. Patients with Active Ocular Disease.
2. Intake of ocular medication that might affect Intra Ocular Pressure.
3. Hypersensitivity to study medications.
4. Ocular inflammation and infection with in past 3 months.
5. Ocular surgery in past 2 months.
6. Ocular trauma within past 2 months.
7. Glaucoma other than Primary Open Angle Glaucoma.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1) Signs and Symptoms : Headache, Eyeache, Delayed dark adaptation, Difficulty in <br/ ><br>visual field, Difficulty in reading and close work. <br/ ><br>2) Visual Analogue Scale (VAS) scoring for eye ache and headache <br/ ><br>3) Intra ocular pressure assessment using Goldmann’s Applanation Tonometer. <br/ ><br>4) Intraocular Pressure change from baseline at each visit. <br/ ><br>5) Number of patients achieving IOP 18 mm Hg at end of treatment.Timepoint: total time duration of the study is 1 year. <br/ ><br> <br/ ><br>primary outcome will be assessed at 0, 4 and 8 weeks
- Secondary Outcome Measures
Name Time Method 1) Visual acuity assessment (at each visit). <br/ ><br>2) Visual field defect with Automated Perimetry (at start and end of treatment). <br/ ><br>3) Dilated fundoscopy at start and at an end <br/ ><br>4) National Eye Institute Visual Functioning Questionnaire (NEI -VFQ 25) scale <br/ ><br>5) Glaucoma Symptoms Scale <br/ ><br>6) Glaucoma quality of life questionnaireTimepoint: 1) and 2) will be done at baseline, 4 and 8 weeks <br/ ><br>3) 4) 5) and 6) will be done at 0 and 8 weeks