Conditions: Allergic Conjunctivitis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 144
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: KetoNaph (ketotifen fumarate 0.025%, naphazoline HCl 0.05%) ophthalmic solution arm 2: Naphazoline HCl 0.05% ophthalmic solution arm 3: Ketotifen fumarate 0.025% ophthalmic solution arm 4: Vehicle of KetoNaph ophthalmic solution

Interventions: intervention 1: Ketotifen/naphazoline intervention 2: Ketotifen intervention 3: Naphazoline intervention 4: Vehicle
Intervention descriptions: intervention 1: One drop of ketotifen/naphazoline in study eye at visit 3 and visit 4. intervention 2: One drop of Ketotifen in study eye at visit 3 and visit 4. intervention 3: One drop of naphazoline in study eye at vist 3 and visit 4. intervention 4: One drop of vehicle in study eye at visit 3 and visit 4.

Protocol document: