Comparative efficacy and safety of preserved and preservative-free anti-glaucoma therapy
- Conditions
- Health Condition 1: null- Already diagnosed cases of primary open angle glaucoma or ocular hypertension
- Registration Number
- CTRI/2016/06/007001
- Lead Sponsor
- Government Medical College Patiala
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
•Established cases of POAG or ocular hypertension with IOP controlled on monotherapy of BKC-preserved latanoprost for more than three months.
1 Known lack of ocular hypotensive response to topical ophthalmic, prostaglandin analogs (in the opinion of the investigator).
2 Intraocular conventional surgery or laser surgery within the past one year.
3 Any refractive surgery in study eye .
4 Patients on steroids medication.
5 Ocular trauma within the past 3 months.
6 Patients suffering from Rheumatoid arthritis or any other systemic disease which also causes dry eye.
7 Patients taking any other medication which also causes dry eye.
8 Progressive retinal or optic nerve disease apart from glaucoma.
9 Concurrent infectious/non infectious conjunctivitis, keratitis, or uveitis in either eye.
10 Any abnormality preventing stable applanation tonometry.
11 Use of contact lens for the duration of the study.
12 Any opacity or subject uncooperativeness that restricts adequate examination of the ocular fundus or anterior chamber.
13 Clinically significant ocular disease (e.g., corneal edema, uveitis, severe keratoconjunctivitis sicca) which might interfere with the study,.
14 Clinically significant systemic disease which might interfere with the study.
15 History of non-compliance to medical regimens or unwilling to comply with the study protocol.
16 Patients with hypersensitivity or poor tolerance to any components of the study medication.
17 Angle closure glaucoma or a history of acute angle closure treated with a peripheral iridotomy.
18 Participation in another clinical study within the last thirty (30) days.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction in OSDI score,normal readings of schirmer test and tear film break up time in patients of POAG/ Ocular hypertensionTimepoint: Baseline (0), 6 and 12 weeks
- Secondary Outcome Measures
Name Time Method Reduction in Intraocular pressure (IOP)Timepoint: Baseline (0), 6 and 12 weeks