Safety and Efficacy Study of AL-53817 and AL-78843 Ophthalmic Solutions for Allergic Conjunctivitis

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.

Inclusion criteria

• Sign Informed Consent
• Use of condom by sexually active males for the entire duration of the study.
• Best corrected visual acuity of 55 or greater in each eye as measured by ETDRS (letters read method).
• Able and willing to comply with study protocol and follow protocol instructions.
• Able to avoid any of the topical ocular or systemic excluded medications during the entire study period.
• At least 1 year subject-reported or physician-diagnosed history (prior to Screen Visit) of allergic conjunctivitis during the ragweed season.
• Positive skin prick test for short ragweed allergen within 12 months prior to Screen Visit.
• Significant staff-assessed ocular redness in at least one region in each eye within the 3 hour period of allergen exposure in the EEC (Screen Visits).
• Other protocol-defined inclusion criteria may apply.

Exclusion criteria

• Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for at least 1 week following the last dose of investigational product.
• Presence of any ocular infection, history of ocular Herpes (simplex or zoster) or adenoviral infection in either eye.
• History of any ocular infection, physician or subject diagnosed, within 30 days prior to Screen Visit.
• Presence of glaucoma, past history of, or diagnosis of glaucoma or ocular hypertension.
• Presence of blepharitis, active rosacea affecting the ocular adnexa, meibomian gland dysfunction, follicular conjunctivitis, intraocular inflammation, or preauricular lymphadenopathy or any other ophthalmic abnormality that may affect the study outcomes.
• Corneal conditions affecting the corneal structure.
• Unwilling to discontinue contact lens wear during the study period.
• Any ocular surgery including ocular laser procedures within 1 year prior to Screen Visit.
• Current or recent (<6 months prior to Screen Visit) history of severe, unstable, or uncontrolled autoimmune, neurological, cardiovascular, hematological, hepatic, renal, psychological, respiratory, gastrointestinal and/or immunological disease or evidence of other diseases based upon a review of medical history and/or physical examination that, in the opinion of the Investigator, would preclude safe subject participation in the study.
• Receiving treatment for anxiety and/or depression at the Screen Visit; any history of suicide attempt.
• Participation in any investigational study within 30 days of Screen Visit or concomitantly with this study.
• Known contraindications or hypersensitivities to any of the study medications or their components
• Confirmed (by physician or optometrist) diagnosis of dry eye.
• History of sensitivity or adverse reaction to steroids.
• Known allergic reaction that is unresponsive to corticosteroids or non-steroidal anti-inflammatory drugs (NSAIDS).
• Physician diagnosed asthma (except inactive childhood asthma and exercise-induced asthma).
• Evidence of active inflammation in the eye as determined by the dilated fundus examination conducted at Screen C Visit.
• Any corneal swelling or haze as determined by the slitlamp examination conducted at Screen C Visit.
• Other protocol-defined exclusion criteria may apply.