Efficacy and Safety of an Ophthalmic Solution in Patients With Allergic Conjunctivitis
Condition: Allergic Conjunctivitis
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Intervention: AL-4943A ophthalmic solution; Olopatadine hydrochloride ophthalmic solution, 0.2%; Olopatadine hydrochloride ophthalmic solution, 0.1%; AL-4943A ophthalmic solution vehicle
Intervention MeSH terms: Olopatadine Hydrochloride; Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 902.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Allergic conjunctivitis; Olopatadine HCl solution; Conjunctival Allergen Challenge; Itching eyes; Ocular allergies; PATADAY; PATANOL

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.
    

Eligibility 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.