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: Unspecified glaucoma,

• Registration Number: CTRI/2010/091/001459
• Lead Sponsor: Ajanta Pharma Ltd

Brief Summary

This study is a randomized, comparative, Double blind and multicentric clinical study comparing the safety and efficacy of Tafluprost Ophthalmic solution Vs. Latanoprost eye drop in 200 patients with Glaucoma. Date of first enrollment will be 13 Oct 2010.

Primary efficacy parameters will be mean Values of IOP levels and Ocular signs and symptoms such as Blurred vision, halos around lights, pain and redness of eyes will be assessed at baseline visit, all follow up visits and at final visit.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10-22
• Last Update Posted: 2018-11-22

Recruitment & Eligibility

• Status: Completed
• Sex: All
• 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.	Day 1, week 1, week 2 and week 4.

Secondary Outcome Measures

Name	Time	Method
Overall global assessment of efficacy and tolerability	Week 4

Trial Locations

Locations (4)

Deeksha Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Kamala Eye and Maternity Home; 🇮🇳 Thane, MAHARASHTRA, India

Murlidhar Nursing and Maternity home; 🇮🇳 Thane, MAHARASHTRA, India

Neha Eye & ENT hospital; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Deeksha Hospital

🇮🇳Bangalore, KARNATAKA, India

Dr. Niveditha. H

Principal investigator