Safety and Efficacy Study of AL-53817 and AL-78843 Ophthalmic Solutions for Allergic Conjunctivitis
Condition: Allergic Conjunctivitis
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Intervention: AL-53817 Ophthalmic Solution, 0.1%; AL-78843 Ophthalmic Solution, 0.03%; Dexamethasone Ophthalmic Suspension, 0.1%; AL-53817 Vehicle
Intervention description: Inactive ingredients used for masking purposes
Intervention MeSH terms: Dexamethasone; Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 224.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Allergic conjunctivitis; Red eyes; Eyelid swelling; Ragweed; Allergies; Itchy eyes; Ocular redness; Chemosis; Tearing; Watery eyes

Summary:

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

Eligibility criteria:

        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.