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

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.

Study Overview

• Status: Completed
• Conditions: Allergic Conjunctivitis
• Intervention / Treatment: Drug: Olopatadine 0.2% Vehicle; Drug: Olopatadine Hydrochloride Ophthalmic Solution 0.2%; Drug: Olopatadine Hydrochloride Ophthalmic Solution 0.1%

• Study Type: Interventional
• Enrollment (Actual): 383
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: Olopatadine 0.2% Vehicle; Inactive ingredients used as placebo comparator; Drug: Olopatadine Hydrochloride Ophthalmic Solution 0.2%; Other Names: PATADAY®
Active Comparator: PATANOL; 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%; Other Names: PATANOL®

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Master, Clinical Medicine, Alcon (China) Ophthalmic Product Co., Ltd.

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: December 17, 2014
• First Submitted That Met QC Criteria: December 17, 2014
• First Posted (Estimate): December 23, 2014

Study Record Updates

• Last Update Posted (Actual): November 17, 2017
• Last Update Submitted That Met QC Criteria: October 17, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Allergies; Ocular
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Eye Diseases; Hypersensitivity; Conjunctival Diseases; Conjunctivitis; Conjunctivitis, Allergic; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Anti-Allergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Histamine H1 Antagonists, Non-Sedating; Ophthalmic Solutions; Pharmaceutical Solutions; Olopatadine Hydrochloride
• Other Study ID Numbers: C-12-010 (EXC458-C001); 2016-004317-27 (EudraCT Number)