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).
- Conditions
- Health Condition 1: H108- Other conjunctivitisHealth Condition 2: null- Seasonal Allergic conjunctivitis
- Registration Number
- CTRI/2010/091/000329
- Lead Sponsor
- Ajanta Pharma Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
1. History of seasonal allergic conjunctivitis.
2. Presence of bilateral ocular itching/conjunctival hyperemia (redness) at baseline.
3. Written informed consent to participate in the trial.
1. 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 examinationTimepoint: Day 0, Day 3, Day 7 and Day 14.
- Secondary Outcome Measures
Name Time Method Global assessmentTimepoint: Day 14;Redness of eye, Ocular itching, eyelid swelling, tearing, photophobia, mucous discharge, foreign body sensationTimepoint: Day 0, Day 3, Day 7 and Day 14.;safety and tolerabilityTimepoint: Day 0,Day 3, Day 7 and Day 14.