CTRI/2010/091/000329
Completed
Phase 3
A Comparative, Randomized, Double blind, Multicentric, Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Desonide 0.25% ophthalmic solution vs. Ketorolac tromethamine 0.5% ophthalmic solution in patients with Seasonal Allergic conjunctivitis.
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: H108- Other conjunctivitisHealth Condition 2: null- Seasonal Allergic conjunctivitis
- Sponsor
- Ajanta Pharma Ltd
- Enrollment
- 100
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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