Evaluation of Prednisolone in a Modified Conjunctival Allergen Challenge Model

Chronic Allergic Conjunctivitis Clinical Trial

Official title: A Single-Center, Double-Masked, Randomized, Placebo-Controlled Evaluation of Prednisolone Sodium Phosphate Ophthalmic Solution, 1% Compared to Placebo in a Modified Conjunctival Allergen Challenge (CAC) Model

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate the effectiveness of the modified Conjunctival Allergen Challenge (CAC) and observe how the produced allergic inflammation reacts to treatment with a proven ocular anti-inflammatory medication,

Prednisolone, assessed by the following measures:

Chronic Allergic Inflammation assessed using confocal microscopy Ocular itching Conjunctival redness

Clinical Trial Description

Prospective, single center, randomized, double-masked, placebo controlled study. Subjects will be randomized to one of the following treatment arms to dose four times per day (QID) for 4 days between Visits 3 and 4.

Prednisolone phosphate Tears Naturale II Ophthalmic Solution (Placebo)

Duration:

Approximately 2 weeks

Controls:

Artificial Tears (Tears Naturale® II) ;

Related Conditions & MeSH terms

• Chronic Allergic Conjunctivitis
• Conjunctivitis
• Conjunctivitis, Allergic

• NCT number: NCT01730872
• Study type: Interventional
• Source: ORA, Inc.
• Status: Completed
• Phase: Phase 4
• Start date: November 2012
• Completion date: December 2012