A clinical Trial in patients with Seasonal Allergic conjunctivitis.Clinical trial is to study efficacy, safety and tolerability of Desonide ophthalmic solution in comparison to Ketorolac Tromethamine ophthalmic solution (reference product).

Phase 3

Completed

• Conditions: Other conjunctivitis, Seasonal Allergic conjunctivitis,

• Registration Number: CTRI/2010/091/000329
• Lead Sponsor: Ajanta Pharma Ltd

Brief Summary

This study is a Comparative, Randomized, Double blind, Multicentric, Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Desonide 0.25% ophthalmic solution and Ketorolac tromethamine 0.5% ophthalmic solution in 100 patients with Seasonal Allergic conjunctivitis. Date of first enrollment will be 12 April 2010. xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /

 The primary outcome measures will be slit lamp examination at day 0, Day 3, Day 7 and Day 14. The secondary outcome measures will be assessed Redness of eye, Ocular itching, eyelid swelling, tearing, photophobia, mucous discharge, foreign body sensation  at Day 0, Day 3, Day 7 and Day 14, safety and tolerability at Day 0, Day 3, Day 7 and Day 14 & Global assessment Day 14.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-04
• Last Update Posted: 2018-11-24

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• History of seasonal allergic conjunctivitis.
• Presence of bilateral ocular itching/conjunctival hyperemia (redness) at baseline.
• Written informed consent to participate in the trial.

Exclusion Criteria

• Patients < 18 & > 60 years.2. A history of hypersensitivity to corticosteroids.3. Active bacterial or viral conjunctivitis or history of ocular herpes.4. Presence or history of severe dry eye.5. Use of contact lenses during the course of the study.6. Bestcorrected visual acuity (Snellen) in either eye worse than 20/100.7. History of ocular surgery or laser within the previous 6 months;8.
• Use of topical (ocular) or systemic corticosteroids within 2 weeks before the start of the study;9.
• Participation in a clinical trial with an investigation drug within 30 days proceeding day one of this study.10.
• Any condition that, in the opinion of the investigator, does not justify the patient?s inclusion in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
slit lamp examination	Day 0, Day 3, Day 7 and Day 14.

Secondary Outcome Measures

Name	Time	Method
safety and tolerability	Day 0,Day 3, Day 7 and Day 14.
Redness of eye, Ocular itching, eyelid swelling, tearing, photophobia, mucous discharge, foreign body sensation	Day 0, Day 3, Day 7 and Day 14.
Global assessment	Day 14

Trial Locations

Locations (4)

Aarupadai Veedu Medical College and Hospital; 🇮🇳 Pondicherry, PONDICHERRY, India

Deeksha Hospital; 🇮🇳 Bangalore, KARNATAKA, India

OM Netralaya; 🇮🇳 Pune, MAHARASHTRA, India

Vinit Netralaya; 🇮🇳 Latur, MAHARASHTRA, India

Aarupadai Veedu Medical College and Hospital

🇮🇳Pondicherry, PONDICHERRY, India

Dr.K. Rathna Kumar

Principal investigator

09443877019

drkrkumar@gmail.com