Olopatadine Hydrochloride Ophthalmic Solution Study in Chinese Subjects

NCT ID: NCT02322216

Last Updated: 2017-11-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 383 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2015-10-31

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.

Conditions

Allergic Conjunctivitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

PATADAY

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

Group Type: EXPERIMENTAL

Olopatadine Hydrochloride Ophthalmic Solution 0.2%

Intervention Type: DRUG

Olopatadine 0.2% Vehicle

Intervention Type: DRUG

Inactive ingredients used as placebo comparator

PATANOL

Olopatadine hydrochloride ophthalmic solution 0.1%, 1 drop in each eye in the morning and evening, for 14 days

Group Type: ACTIVE_COMPARATOR

Olopatadine Hydrochloride Ophthalmic Solution 0.1%

Intervention Type: DRUG

Interventions

Olopatadine Hydrochloride Ophthalmic Solution 0.2%

Intervention Type: DRUG

Olopatadine Hydrochloride Ophthalmic Solution 0.1%

Intervention Type: DRUG

Olopatadine 0.2% Vehicle

Inactive ingredients used as placebo comparator

Intervention Type: DRUG

Other Intervention Names

PATADAY®; PATANOL®

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;

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;

• Minimum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Master, Clinical Medicine

Role: STUDY_DIRECTOR

Alcon (China) Ophthalmic Product Co., Ltd.

Other Identifiers

2016-004317-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

C-12-010 (EXC458-C001)

Identifier Type: -

Identifier Source: org_study_id