NCT01534195

Evaluation of the Efficacy of Topical Ophthalmic Steroids in a Modified Conjunctival Allergen Challenge (CAC) Model

A Phase 4, Randomized, Double-Masked, Single Center, Placebo-Controlled Adaptive Clinical Trial, Using Prednisolone Sodium Phosphate Ophthalmic Solution, 1%, in Subjects With Allergic Conjunctivitis to Evaluate a Modified Conjunctival Allergen Challenge (CAC) Model

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: ORA, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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: * Ocular itching * Conjunctival redness

Detailed 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 8 days between Visits 4 and 5. * Prednisolone phosphate * Tears Naturale II Ophthalmic Solution (Placebo) Duration: Approximately 19 days Controls: Artificial Tears (Tears Naturale® II)

Conditions

• Allergic Conjunctivitis

Interventions

Type	Name	Description
DRUG	Prednisolone Sodium Phosphate Ophthalmic Solution 1%	One drop in each eye, four times/day for 8 days.
DRUG	Tears Naturale II Ophthalmic Solution	one drop in each eye, four times/ day (QID) for 8 days

Timeline

• Start date: 2012-01-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2012-02-16
• Last updated: 2019-03-26
• Results posted: 2019-01-15

Locations

1 site across 1 country: United States