Conditions: Allergic Conjunctivitis
Keywords: Allergic conjunctivitis Red eyes Eyelid swelling Ragweed Allergies Itchy eyes Ocular redness Chemosis Tearing Watery eyes
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 224
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate two investigational ophthalmic solutions for reduction in ocular redness in subjects with allergic conjunctivitis.

Detailed description:
Eligible subjects attended 8 study visits, 5 of which included a 3-hour period of ragweed exposure in an Environmental Exposure Chamber. At the sixth visit, subjects received study product and began dosing for up to 9 days. The final visit was the final day of dosing. Participation in this study lasted up to 68 days.

Arms:
arm 1: AL-53817 Ophthalmic Solution, 0.1%, 1 drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9) arm 2: AL-78843 Ophthalmic Solution, 0.03%, 1 drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9) arm 3: Dexamethasone Ophthalmic Suspension, 0.1%, 1 drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9) arm 4: AL-53817 Vehicle, 1 drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)

Interventions: intervention 1: AL-53817 Ophthalmic Solution, 0.1% intervention 2: AL-78843 Ophthalmic Solution, 0.03% intervention 3: Dexamethasone Ophthalmic Suspension, 0.1% intervention 4: AL-53817 Vehicle
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: Inactive ingredients used for masking purposes

Protocol document: