A Clinical trial to check the effect, Safety and Tolerability of Ripasudil Hydrochloride Hydrate Eye Drops 0.4% w/v Vs Timolol Maleate Eye Drops 0.5% w/v in patients with Ocular Hypertension / Glaucoma

A Comparative, Randomized, Two Arm, Double Blind, Parallel group, Multicentric Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Ripasudil Hydrochloride Hydrate Eye Drops 0.4% w/v Vs Timolol Maleate Eye Drops 0.5% w/v in Subjects Suffering from Ocular Hypertension / Glaucoma.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/04/013091

Enrollment

240

Registered

2018-04-06

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Ocular Hypertension/Glaucoma Health Condition 2: H408- Other glaucoma

Interventions

Intervention1: Ripasudil Hydrochloride Hydrate Eye Drops 0.4% w/v: Instill one drop in the affected eye twice daily for 90 days Control Intervention1: Timolol Maleate Eye Drops 0.5% w/v: Instill one d

Eligibility

Inclusion criteria

Inclusion criteria: 1.Subjects with IOP between 22mm Hg â?? 30mm Hg at the time of screening in any one eye. Incase 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. 2.Voluntary willingness of patient to give written informed consent prior to participation in trial.

Exclusion criteria

Exclusion criteria: 1.Women who are not using an effective means of contraception or who are pregnant or nursing. 2.Subjects with any severe or advanced cases of Glaucoma 3.Shaffer angle grade 20]), as measured by Gonioscopy. 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.Subject who are schedule to undergo surgery of the eye during the study period. 8.History of/current chronic, recurrent or severe inflammatory eye disease (eg: scleritis, uveitis, herpes keratitis) or current other severe ocular pathology (including severe dry eye) that would affect the conduct of the study. 9.History of ocular trauma or any other intraocular surgery within the past 6 months in either eye. 10.Current/history of ocular infection or inflammation within the past 3 months as determined by patient history and/or eye examination.

Design outcomes

Primary

Measure	Time frame
Mean reduction in the IOP from baseline to end of study visit.Timepoint: Day 0 and Day 90	—

Secondary

Measure	Time frame
Mean reduction in the phasing of IOP from baseline to end of study visit.Timepoint: Day 0 and Day 90	—

Countries

India

Contacts

Public ContactDr Shailesh Singh

Ajanta Pharma Limited

shailesh.singh@ajantapharma.com2266062111

Outcome results

None listed

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