Clinical trial NCT02322216: Olopatadine Hydrochloride Ophthalmic Solution Study in Chinese Subjects
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allergic Conjunctivitis
Keywords: Allergies
Ocular
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2014-12-23
Enrollment: 383
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: Change From Baseline in Worst Ocular Itching Score During the 24 Hours Prior at Day 14
timeFrame: Baseline, Day 14
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Alcon (China) Ophthalmic Product Co., Ltd.
name: Master, Clinical Medicine
role: STUDY_DIRECTOR
References: