Olopatadine Hydrochloride Ophthalmic Solution Study in Chinese Subjects

NCT02322216 | Completed Phase 3 Results

• 2 other identifiers: C-12-010 (EXC458-C001)2016-004317-27
• Study Type: interventional
• Target: 383
• Locations: 0 countries
• Sites: N/A

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

Keywords

Allergies; Ocular

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

PATADAY

EXPERIMENTAL

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 Hydrochloride Ophthalmic Solution 0.2%; Drug: Olopatadine 0.2% Vehicle

PATANOL

ACTIVE COMPARATOR

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%

Interventions

Olopatadine Hydrochloride Ophthalmic Solution 0.2% DRUG

Also known as: PATADAY®

PATADAY

Olopatadine Hydrochloride Ophthalmic Solution 0.1% DRUG

Also known as: PATANOL®

PATANOL

Olopatadine 0.2% Vehicle DRUG

Inactive ingredients used as placebo comparator

PATADAY

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Conjunctivitis, Allergic; Hypersensitivity

Interventions

Olopatadine Hydrochloride

Condition Hierarchy (Ancestors)

Conjunctivitis; Conjunctival Diseases; Eye Diseases; Hypersensitivity, Immediate; Immune System Diseases

Intervention Hierarchy (Ancestors)

Dibenzoxepins; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Clinical Project Lead, GCRA-Pharma
• Organization: Alcon, a Novartis Company

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Master, Clinical Medicine

  Alcon (China) Ophthalmic Product Co., Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2014
• First Posted: December 23, 2014
• Study Start: December 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: November 17, 2017
• Results First Posted: October 12, 2016

Record last verified: 2017-10