Efficacy and Safety of AL-4943A Ophthalmic Solution in Patients With Allergic Conjunctivitis Using the Conjunctival Allergen Challenge (CAC) Model
Condition: Allergic Conjunctivitis
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Intervention: AL-4943A ophthalmic solution; AL-4943A vehicle; Olopatadine hydrochloride ophthalmic solution, 0.2%
Intervention description: Inactive ingredients used as placebo
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: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 397.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Allergic Conjunctivitis; Ocular Allergy

Summary:

      The purpose of this study was to assess the safety and efficacy of AL-4943A 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.

          -  Diagnostic skin test indicative of allergy for cat hair, cat dander, grasses, ragweed,
             dust mite, dog dander, cockroach and/or trees within 24 months of Visit 1.

          -  History of seasonal or perennial allergic conjunctivitis for at least 1 year prior to
             Visit 1.

          -  Positive bilateral CAC response at Visit 1 and Visit 2.

          -  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 requiring
             frequent use (> 4 days per week) of artificial tears, gels or lubricants, presence of
             punctal plugs, use of Restasis®, or topical ocular corticosteroids for dryness of
             eyes.

          -  Presence of active blepharitis, active meibomian gland dysfunction, active rosacea
             affecting the ocular adnexa, follicular conjunctivitis, iritis, preauricular
             lymphadenopathy, ocular irritation not due to ocular allergy, or any other clinically
             significant ophthalmic abnormality that may affect the study outcomes.

          -  Presumed or actual ocular infection (bacterial, viral or fungal) or history of ocular
             herpes in either eye as determined by patient history and/or examination within 30
             days of Visit 1.

          -  Presence of any chronic ocular degenerative condition or active intra-ocular
             inflammation in either eye that in the opinion of the Investigator is likely to
             advance/worsen during the time course of the study.

          -  Any contraindications or hypersensitivities to the use of the study medication or
             their components.

          -  Other protocol-defined exclusion criteria may apply.