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Hydrocortisone Ophthalmic Ointment 0.5% for Treatment of Allergic Conjunctivitis

Allergic Conjunctivitis Clinical Trial

Official title:
Phase 2 EFFICACY AND SAFETY OF HYDROCORTISONE OPHTHALMIC OINTMENT - VERSUS PLACEBO IN THE TREATMENT OF ALLERGIC CONJUNCTIVITIS

Clinical Trial Summary

The purpose of this study is to determine the safety and effectiveness of hydrocortisone ophthalmic ointment compared to placebo in the treatment of Allergic Conjunctivitis.

Clinical Trial Description

Compare the safety and efficacy of Hydrocortisone Ophthalmic Ointment 0.5% vs. Placebo for the reduction of signs and symptoms associated with allergic conjunctivitis. Demonstration of efficacy is a statistically significant improvement in itching on a 0 to 4 patient subjective assessment itch score compared to the vehicle arm and at least a 25% (or 1 full unit or more) improvement in itch scores. Efficacy for bulbar redness scores would be indicated by a statistically significant improvement in redness on a zero to 4 based on the investigators objective assessment compared to the vehicle group. Differences of at least 25% on the four point scale would be considered clinically significant when attained at the majority of time points. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01860664
Study type Interventional
Source Koffler Vision Group
Contact
Status Terminated
Phase Phase 2
Start date May 2013
Completion date January 1, 2017
View Details
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