NCT00689078

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

Single Center, Randomized, Double-Masked Evaluation of the Efficacy of PredAcetate 1% Ophthalmic Suspension Compared to Pred Acetate 0.12% Ophthalmic Suspension, Lot Etab 0.2% Ophthalmic Suspension, and Placebo in a Modified CAC Model

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: ORA, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy of prednisolone acetate 1% ophthalmic suspension as compared to prednisolone acetate 0.12% ophthalmic suspension, loteprednol etabonate 0.2% ophthalmic suspension, and placebo (Tears Naturale® II) in the prevention of the signs and symptoms of allergic conjunctivitis. Comparisons will be made following 1 week of twice daily (BID) dosing and 1 week of four times daily (QID) dosing.

Detailed description

Structure: Prospective, single center, randomized, double-masked, parallel treatment comparison study. Subjects will be randomized to one of the following treatment arms to be dosed bilaterally twice daily (BID) for the first dosing period and four times daily (QID) for the second dosing period: 1. Prednisolone Acetate 1% ophthalmic suspension 2. Prednisolone Acetate 0.12% ophthalmic suspension 3. Loteprednol Etabonate 0.2% ophthalmic suspension 4. Tears Naturale® II Duration: Approximately four (4) weeks Controls: Artificial Tears (Tears Naturale® II)

Conditions

• Allergic Conjunctivitis

Interventions

Type	Name	Description
DRUG	Prednisolone Acetate 1%	One drop in both eyes (OU) BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days.
DRUG	Prednisolone Acetate 0.12%	One drop in both eyes (OU) BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days.
DRUG	Loteprednol Etabonate 0.2%	One drop in both eyes (OU) BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days.
DRUG	Placebo	One drop in both eyes (OU) BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days.

Timeline

• Start date: 2008-05-01
• Primary completion: 2008-06-01
• Completion: 2008-06-01
• First posted: 2008-06-03
• Last updated: 2020-09-02
• Results posted: 2018-11-15

Locations

1 site across 1 country: United States