Olopatadine Hydrochloride Ophthalmic Solution Study in Chinese Subjects

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

Sponsors

Lead Sponsor: Alcon Research

Source Alcon Research
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.

Overall Status Completed
Start Date December 2014
Completion Date October 2015
Primary Completion Date October 2015
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Change From Baseline in Worst Ocular Itching Score During the 24 Hours Prior at Day 14 Baseline, Day 14
Enrollment 383
Condition
Intervention

Intervention Type: Drug

Intervention Name: Olopatadine Hydrochloride Ophthalmic Solution 0.2%

Arm Group Label: PATADAY

Other Name: PATADAY®

Intervention Type: Drug

Intervention Name: Olopatadine Hydrochloride Ophthalmic Solution 0.1%

Arm Group Label: PATANOL

Other Name: PATANOL®

Intervention Type: Drug

Intervention Name: Olopatadine 0.2% Vehicle

Description: Inactive ingredients used as placebo comparator

Arm Group Label: PATADAY

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.

Gender: All

Minimum Age: 10 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Master, Clinical Medicine Study Director Alcon (China) Ophthalmic Product Co., Ltd.
Verification Date

October 2017

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: PATADAY

Type: Experimental

Description: 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

Label: PATANOL

Type: Active Comparator

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

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Single (Investigator)

Source: ClinicalTrials.gov