A clinical Trial in patients with Glaucoma. Clinical trial is to study efficacy, safety and tolerability of Tafluprost Ophthalmic solution in comparison to Latanoprost eye drop (reference product).
Phase 3
Completed
- Conditions
- Health Condition 1: null- GlaucomaHealth Condition 2: H409- Unspecified glaucoma
- Registration Number
- CTRI/2010/091/001459
- Lead Sponsor
- Ajanta Pharma Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
Inclusion Criteria
1.Patients with diagnosis of glaucoma.
Exclusion Criteria
Pregnant or nursing females.
Patients with exfoliation glaucoma and neovascular glaucoma.
Patients with diabetic retinopathy.
Patients with advanced visual field loss (MD <-15dB).
Excessive myopia (<-6D).
Any corneal abnormality or other condition preventing reliable applanation tonometry.
Presence of any external disease and inflammation of the eye.
History of refractive surgery.
History of laser trabeculoplasty, filtering surgery, trabeculotomy, cataract surgery, and other intraocular surgery.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Blurred Vision, Halos around Lights, Pain and Redness of Eye.Timepoint: Day 1, week 1, week 2 and week 4.;Blurred Vision, Halos around Lights, Pain and Redness of Eye.Timepoint: Day 1, week 1, week 2 and week 4.
- Secondary Outcome Measures
Name Time Method Overall global assessment of efficacy and tolerabilityTimepoint: Week 4