NCT01860664

Hydrocortisone Ophthalmic Ointment 0.5% for Treatment of Allergic Conjunctivitis

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Koffler Vision Group · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Allergic Conjunctivitis

Interventions

Type	Name	Description
DRUG	hydrocortisone ophthalmic ointment 0.5%	* Patients will be instructed to apply Hydrocortisone Ophthalmic Ointment 0.5% or placebo in the lower cul de sac or lid margin BID * Patients will be instructed to not use the study medications at least 2 hours prior to their appointment. * Study medication dosing details: * 0.05 grams hydrocortisone per gram of combination product * each application equal to 1/20th of a gram * total amount of active ingredient applied to each eye per application = 0.0025 grams hydrocortisone * total amount hydrocortisone applied per eye per day = 0.005 grams hydrocortisone * Total amount of active ingredient applied per eye throughout duration of the two week study = 0.07 grams hydrocortisone
DRUG	placebo	Mineral oil and white petrolatum

Timeline

• Start date: 2013-05-01
• Primary completion: 2016-05-01
• Completion: 2017-01-01
• First posted: 2013-05-23
• Last updated: 2017-08-18

Locations

1 site across 1 country: United States