To find out Ripasudil is safe and efficient drug than Timolol in Primary Open Angle Glaucoma

TO COMPARE THE EFFICACY AND SAFETY OF RIPASUDIL VERSUS TIMOLOL IN PRIMARY OPEN ANGLE GLAUCOMA - POGlaRT

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/07/035000

Enrollment

Registered

2021-07-20

Start date

Unknown

Completion date

Unknown

Last updated

2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H401- Open-angle glaucoma

Interventions

Intervention1: Ripasudil eye drops: Group A- Ripasudil 0.4 % w/v Ophthalmic solution BID for 8 weeks Control Intervention1: Timolol eye drops: Group B- Timolol 0.5% w/v Ophthalmic Solution BID for 8

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
1) Signs and Symptoms : Headache, Eyeache, Delayed dark adaptation, Difficulty in visual field, Difficulty in reading and close work. 2) Visual Analogue Scale (VAS) scoring for eye ache and headache 3) Intra ocular pressure assessment using Goldmann’s Applanation Tonometer. 4) Intraocular Pressure change from baseline at each visit. 5) Number of patients achieving IOP 18 mm Hg at end of treatment.Timepoint: total time duration of the study is 1 year. primary outcome will be assessed at 0, 4 and 8 weeks	—

Measure

Time frame

1) Signs and Symptoms : Headache, Eyeache, Delayed dark adaptation, Difficulty in visual field, Difficulty in reading and close work. 2) Visual Analogue Scale (VAS) scoring for eye ache and headache 3) Intra ocular pressure assessment using Goldmann’s Applanation Tonometer. 4) Intraocular Pressure change from baseline at each visit. 5) Number of patients achieving IOP 18 mm Hg at end of treatment.Timepoint: total time duration of the study is 1 year. primary outcome will be assessed at 0, 4 and 8 weeks

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Secondary

Measure	Time frame
1) Visual acuity assessment (at each visit). 2) Visual field defect with Automated Perimetry (at start and end of treatment). 3) Dilated fundoscopy at start and at an end 4) National Eye Institute Visual Functioning Questionnaire (NEI -VFQ 25) scale 5) Glaucoma Symptoms Scale 6) Glaucoma quality of life questionnaireTimepoint: 1) and 2) will be done at baseline, 4 and 8 weeks 3) 4) 5) and 6) will be done at 0 and 8 weeks	—

Measure

Time frame

1) Visual acuity assessment (at each visit). 2) Visual field defect with Automated Perimetry (at start and end of treatment). 3) Dilated fundoscopy at start and at an end 4) National Eye Institute Visual Functioning Questionnaire (NEI -VFQ 25) scale 5) Glaucoma Symptoms Scale 6) Glaucoma quality of life questionnaireTimepoint: 1) and 2) will be done at baseline, 4 and 8 weeks 3) 4) 5) and 6) will be done at 0 and 8 weeks

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Countries

India

Contacts

Public ContactDr Saurabh D Patil

Pt. B. D. Sharma PGIMS, Rohtak

saurabh20_phar.pgims@uhsr.ac.in9823149105

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026