NCT01730872

Evaluation of Prednisolone in a Modified Conjunctival Allergen Challenge Model

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 16 (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: Chronic Allergic Inflammation assessed using confocal microscopy 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 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)

Conditions

• Chronic Allergic Conjunctivitis

Interventions

Type	Name	Description
DRUG	Prednisolone Sodium Phosphate Ophthalmic Solution 1%	One drop in each eye, four times/day for 4 days.
DRUG	Tears Naturale II Ophthalmic Solution	one drop in each eye, four times/ day (QID) for 4 days

Timeline

• Start date: 2012-11-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2012-11-21
• Last updated: 2019-06-19
• Results posted: 2019-06-19

Locations

1 site across 1 country: United States