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Olopatadine Hydrochloride Ophthalmic Solution Study in Chinese Subjects

Information source: Alcon Research
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Allergic Conjunctivitis

Intervention: Olopatadine Hydrochloride Ophthalmic Solution 0.2% (Drug); Olopatadine Hydrochloride Ophthalmic Solution 0.1% (Drug); Olopatadine 0.2% Vehicle (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Alcon Research

Official(s) and/or principal investigator(s):
Miao Guo, Master, Clinical Medicine, Study Director, Affiliation: Alcon Research

Overall contact:
Alcon (China) Ophthalmic Product Co., LTD, Phone: 8610 58291588


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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Primary outcome: Change from baseline in worst ocular itching score during the 24 hours prior at Day 14


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


- 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.

Locations and Contacts

Alcon (China) Ophthalmic Product Co., LTD, Phone: 8610 58291588

Contact Alcon China for Trial Locations, Beijing 100016, China; Recruiting
Additional Information

Starting date: December 2014
Last updated: July 1, 2015

Page last updated: August 23, 2015

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