A clinical trial to study and compare the effects of two once a daily eye drops in patients with open angle Glaucoma and ocular hypertension.

Comparison of the efficacy and safety of Latanoprost 0.005% (XalatanÂ® Reference) and Latanoprost 0.005% (Sun Pharma Advanced Research Company Ltd) administered once daily in open angle glaucoma and ocular hypertension.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2011/12/002313

Enrollment

100

Registered

2011-12-30

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: H401- Open-angle glaucoma Health Condition 2: null- Patients with Glaucoma and ocular hypertension

Interventions

Intervention1: Latanoprost (Bezalkonium Chloride free): Latanoprost 0.005% (Sun Pharma Advanced Research Company Ltd.). One drop daily for 4 weeks Control Intervention1: Latanoprost: Latanoprost 0.005

Eligibility

Inclusion criteria

Inclusion criteria: Men and women aged 18 years and above. Unmedicated IOP equal to or greater than 22 mmHg in one or both eyes Visual acuity 6/60 or better Willingness to participate and giving written informed consent Willing to commit to study medication-dosing, study visits and follow-up visits to complete evaluation

Exclusion criteria

Exclusion criteria: Pigmentary glaucoma Intraocular conventional surgery or laser surgery within the past six months Refractive surgery in study eye Angle closure glaucoma or a history of acute angle closure treated with a peripheral iridotomy Ocular trauma within the past 3 months Progressive retinal or optic nerve disease apart from glaucoma Concurrent infectious/non infectious conjunctivitis, keratitis, or uveitis in either eye Contact lens wear within 15 minutes of instillation of study medication Women of childbearing potential who have positive serum pregnancy test or are lactating or not using adequate contraception Clinically significant systemic disease, which might interfere with the study History of non-compliance to medical regimens or unwilling to comply with the study protocol Participation in another clinical study within the last thirty (30) days Changes in systemic medication within 30 days prior to screening that could have a substantial impact on IOP, or anticipated changes during the study Refusal or inability to give written informed consent

Design outcomes

Primary

Measure	Time frame
IOP at each visitTimepoint: week 1, week 2, week 4	—

Secondary

Measure	Time frame
Cup - to- disc ratioTimepoint: week 1 & week 4;Investigator clinical global impression of changeTimepoint: week 2 & week 4;subject global impression of changeTimepoint: week 2 & week 4	—

Countries

India

Contacts

Public ContactDr Mudgal Kothekar MD

Sun Pharma Advanced Research Company Limited

Clinical.Trials@sparcmail.com912266455645

Outcome results

None listed

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