Conditions: Allergic Conjunctivitis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 141
Healthy volunteers: no

Brief summary:
The purpose of this study is to establish the safety and efficacy of ketotifen/naphazoline ophthalmic solution compared to vehicle and its individual components in alleviating the signs and symptoms of conjunctival allergen challenge (CAC)-induced allergic conjunctivitis.

Detailed description:

Arms:
arm 1: Ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. arm 2: Vehicle of ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. arm 3: Naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. arm 4: Ketotifen ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.

Interventions: intervention 1: Ketotifen/naphazoline intervention 2: Naphazoline intervention 3: Ketotifen intervention 4: Vehicle
Intervention descriptions: intervention 1: One drop of ketotifen fumarate 0.025% and naphazoline HCl 0.05% ophthalmic solution at visit 3 and visit 4. intervention 2: One drop of naphazoline HCl 0.05% ophthalmic solution at visits 3 and 4. intervention 3: One drop of ketotifen fumarate 0.025% ophthalmic solution at visits 3 and 4. intervention 4: One drop of vehicle ophthalmic solution at visit 3 and visit 4.

Protocol document: