Olopatadine Hydrochloride Ophthalmic Solution Study in Chinese Subjects

Allergic Conjunctivitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02322216
• Other study ID #: C-12-010 (EXC458-C001)
• Secondary ID: 2016-004317-27
• Status: Completed
• Phase: Phase 3
• First received: December 17, 2014
• Last updated: October 17, 2017
• Start date: December 2014
• Est. completion date: October 2015

Study information

• Verified date: October 2017
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 383
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Allergic Conjunctivitis
• Conjunctivitis
• Conjunctivitis, Allergic

Intervention

Drug:
• Olopatadine Hydrochloride Ophthalmic Solution 0.2%

• Olopatadine Hydrochloride Ophthalmic Solution 0.1%

• Olopatadine 0.2% Vehicle
Inactive ingredients used as placebo comparator

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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