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.
Minimum age: 10 Years.
Maximum age: N/A.
Gender(s): Both.
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 Visit 1 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 (Visit 1);
- Clinically relevant recent (within 6 months of Visit 1) 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 (Visit 1). 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.