A clinical study to evaluate effect of two drugs bezalkonium chloride free latanoprost ophthalmic solution in patients with glaucoma
- Conditions
- Health Condition 1: H401- Open-angle glaucomaHealth Condition 2: null- Patients with glaucoma
- Registration Number
- CTRI/2010/091/002822
- Lead Sponsor
- Sun Pharma Advanced Research Company Ltd, 17/B, Mahal Industrial Estate, Mahakali Caves Road, Andheri-E, Mumbai-400093, Maharashtra, India.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 46
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Tear break up timeTimepoint: at week 8
- Secondary Outcome Measures
Name Time Method Inferior corneal staining,Conjunctival hyperemia grading,Intra ocular pressure,Ocular surface disease.Timepoint: at week 8