Efficacy and Safety of an Ophthalmic Solution in Patients With Allergic Conjunctivitis

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate an ophthalmic solution for the treatment of ocular itching associated with allergic conjunctivitis using the Conjunctival Allergen Challenge (CAC) model.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alcon Research
• Treatments: Olopatadine Hydrochloride; Ophthalmic Solutions; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• Able to be dosed in both eyes, able and willing to make the required study visits and to follow instructions.

• Negative urine pregnancy test if female of childbearing potential and use adequate birth control throughout the study period.

• Diagnostic skin test indicative of allergy for cat hair, cat dander, grasses, ragweed, dust mite, dog dander, cockroach and/or trees within 24 months prior to Visit 1 or at Visit 1.

• History of seasonal or perennial allergic conjunctivitis for at least 1 year prior to Visit 1.

• Best-corrected visual acuity of 55 or greater in each eye as measured by ETDRS (letters read method).

• Manifest a positive bilateral Conjunctival Allergen Challenge (CAC) test response.

• Willing to discontinue contact lens wear for at least 72 hours prior to Visit 1 and throughout the study.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Known history or presence of persistent dry eye syndrome, or currently requires frequent use of artificial tears, gels or lubricants, presence of punctal plugs, use of Restasis®, or topical ocular corticosteroids for dryness of eyes.

• Presence of an ocular condition that may affect the study outcomes.

• History or evidence of ocular surgery (including refractive procedures such as LASIK, PRK and RK) within 6 months of Visit 1.

• Presence of signs/symptoms of active allergic conjunctivitis at the start of Visits 1, 2, 3A, or 4.

• History of anaphylactic reaction to any allergens used in this study.

• Current evidence or recent (within 6 months) history of severe, unstable, or uncontrolled medical conditions and/or other relevant systemic diseases.

• Use of any disallowed medication without protocol-specified washout period prior to Visit 1, or during the study.

• Other protocol-defined exclusion criteria may apply.