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A clinical study to evaluate effect of two drugs bezalkonium chloride free latanoprost ophthalmic solution in patients with glaucoma

STUDY TO EVALUATE SAFETY OF BENZALKONIUM CHLORIDE FREE LATANOPROST OPHTHALMIC SOLUTION 0.005% IN SUBJECTS WITH GLAUCOMA.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2010/091/002822
Enrollment
40
Registered
2010-12-02
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

Interventions

Intervention1: Latanoprost: 0.005% Control Intervention1: NIL: NIL

Sponsors

Sun Pharma Advanced Research Company Ltd, 17/B, Mahal Industrial Estate, Mahakali Caves Road, Andheri-E, Mumbai-400093, Maharashtra, India.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 18 years of age or older Either gender and any race,taking Latanoprost (containing BAK) monotherapy at least 12 months,tear break up time less than 6 seconds

Exclusion criteria

Exclusion criteria: Participation in another clinical study within the last thirty (30) days,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,Refusal or inability to give written informed consent,Angle closure glaucoma or a history of acute angle closure treated with a peripheral iridotomy,Progressive retinal or optic nerve disease apart from glaucoma,Any opacity or subject uncooperativeness that restricts adequate examination of the ocular fundus or anterior chamber,Clinically significant ocular disease (e.g. corneal edema, uveitis, severe keratoconjunctivitis sicca) which might interfere with the study.

Design outcomes

Primary

MeasureTime frame
Tear break up timeTimepoint: at week 8

Secondary

MeasureTime frame
Inferior corneal staining,Conjunctival hyperemia grading,Intra ocular pressure,Ocular surface disease.Timepoint: at week 8

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