Olopatadine Hydrochloride Ophthalmic Solution Study in Chinese Subjects
Condition: Allergic Conjunctivitis
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Intervention: Olopatadine Hydrochloride Ophthalmic Solution 0.2%; Olopatadine Hydrochloride Ophthalmic Solution 0.1%; Olopatadine 0.2% Vehicle
Intervention description: Inactive ingredients used as placebo comparator
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: Single (Investigator)
Enrollment: 383.0
Sex: All
Minimum age: 10 Years
Healthy volunteers: No
Keywords: Allergies; Ocular

Summary:

      The purpose of this study is to evaluate olopatadine 0.2% QD (once per day) compared to
      olopatadine 0.1% BID (twice per day) in the treatment of ocular itching associated with
      allergic conjunctivitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chinese ethnicity;

          -  History of allergic conjunctivitis within the last 2 years;

          -  Positive skin prick test or skin intradermal test documented by a lab report within 24
             months of, or at the baseline visit;

          -  Clinical diagnosis of allergic conjunctivitis with specific signs and symptoms;

          -  Understand and sign an informed consent form;

          -  Willing and able to make required study visits and follow study instructions, and
             comply with dosing study medication as instructed;

          -  Other protocol-specified inclusion criteria may apply.

        Exclusion Criteria:

          -  Contraindications or hypersensitivity to study medications or their components;

          -  Best-corrected visual acuity (BCVA) score worse than 55 ETDRS letters (equivalent to
             approximately 0.60 logMAR, 20/80 Snellen, or 0.25 decimal) in either eye;

          -  Any ocular condition that could affect the study outcomes;

          -  Presumed or actual ocular infection or history of ocular herpes in either eye;

          -  Known history of retinal detachment, diabetic retinopathy, or any progressive retinal
             disease;

          -  Willing and able to avoid the use of any other topical ocular medication(s) (including
             artificial tear products);

          -  Any significant illness that could be expected to interfere with the study,
             particularly any autoimmune disease;

          -  Intraocular surgery in either eye within 6 months, or ocular laser surgery in either
             eye within 3 months, or anticipation of ocular surgery during the study; ocular trauma
             in either eye within 3 months of baseline visit;

          -  Clinically relevant recent (within 6 months of baseline visit) history of or current
             severe, unstable, or uncontrolled cardiovascular, pulmonary, hepatic, renal,
             autoimmune disease and other relevant systemic diseases that would preclude the safe
             administration of a topical antihistamine/mast cell stabilizer in the opinion of the
             Investigator;

          -  Use of systemic medication(s) on a chronic dosing regimen for less than 1 month or
             have changed dosage within the month prior to baseline visit;

          -  Use of any disallowed medication (topical, topical ophthalmic, systemic and/or
             injectable) during the period indicated prior to baseline visit. These medications are
             also not allowed during the study. Disallowed medications include all anti-allergy
             therapies including those contained in prescription or over-the-counter sleeping aids;

          -  Use of cold compresses on the eyes during the course of the study;

          -  Cannot be dosed in both eyes;

          -  Cannot avoid contact lens wear during the course of the study;

          -  Therapy with another investigational agent within 30 days of baseline visit, or during
             the study;

          -  Women of childbearing potential who are pregnant, intend to become pregnant during the
             study period, breast-feeding, or not using adequate birth control methods;

          -  Other protocol-specified exclusion criteria may apply.