Olopatadine Hydrochloride Ophthalmic Solution Study in Chinese Subjects

Study Overview
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Brief Summary
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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.

Official Title
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A Comparative Study of Olopatadine Hydrochloride Ophthalmic Solution 0.2% QD vs Olopatadine Hydrochloride Ophthalmic Solution 0.1% BID in the Treatment of Allergic Conjunctivitis in Chinese Subjects

Conditions
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Allergic Conjunctivitis

Intervention / Treatment
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* Drug: Olopatadine Hydrochloride Ophthalmic Solution 0.2%
* Drug: Olopatadine Hydrochloride Ophthalmic Solution 0.1%
* Drug: Olopatadine 0.2% Vehicle


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PATADAY<br>Olopatadine hydrochloride ophthalmic solution 0.2% in the morning and olopatadine 0.2% vehicle in the evening, 1 drop in each eye for 14 days | Drug: Olopatadine Hydrochloride Ophthalmic Solution 0.2%<br> <br> * Other names: PATADAY®;Drug: Olopatadine 0.2% Vehicle<br>* Inactive ingredients used as placebo comparator<br>|
| Active Comparator: PATANOL<br>Olopatadine hydrochloride ophthalmic solution 0.1%, 1 drop in each eye in the morning and evening, for 14 days | Drug: Olopatadine Hydrochloride Ophthalmic Solution 0.1%<br> <br> * Other names: PATANOL®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Worst Ocular Itching Score During the 24 Hours Prior at Day 14 | Severity of ocular itching was evaluated as the worst score observed in the past 24 hours prior to each study visit. Ocular itching was assessed by the participant on a scale from 0-4, where 0=None and 4=Incapacitating itch. One eye (study eye) contributed to the analysis. | Baseline, Day 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Allergies, Ocular