Comparison of efficacy of three medicines as a combination eye drop and as three individual eye drops in patients with eye pressure (Glaucoma).

Phase 4

• Conditions: Health Condition 1: H402- Primary angle-closure glaucoma

• Registration Number: CTRI/2024/06/068916
• Lead Sponsor: Investigator initiated study

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Male or non-pregnant female aged 18 years or older with chronic open angle glaucoma or ocular hypertension in both eyes.

2. Provide signed and dated informed consent in accordance with good clinical practice (GCP)

and local legislation prior to any study procedure.

3. Be able and willing to follow study instructions and complete all required visits.

4. Subject requires treatment of both eyes and is able to discontinue use of all ocular hypotensive medication(s) or switch ocular hypotensive medications and undergo appropriate washout period.

5. Baseline (Day 0/hour 0) IOP = 22 mm Hg and = 34 mm Hg in each eye and any asymmetry of IOP between the eyes no greater than 5 mm Hg.

6. Have a best spectacle-corrected visual acuity (BSCVA) equivalent to 20/200 or better in each

eye.

7. Adequate wash-out period prior to baseline of any ocular hypotensive medication.

Exclusion Criteria

1. Subjects with angle closure glaucoma

2. Females who are pregnant, breast feeding, or planning a pregnancy.

3. Females of childbearing potential who do not agree to utilize an adequate form of contraception. 4. Current, or past history of, severe hepatic or renal impairment

5. Current, or history within 2 months prior to baseline of, significant ocular disease, e.g., corneal edema, uveitis, ocular infection, or ocular trauma in either eye.

6. Current corneal abnormalities that would prevent accurate IOP readings with the Goldmann applanation tonometer.

7. Functionally significant visual field loss

Study & Design

• Study Type: PMS
• Study Design: Not specified