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
Verified date | October 2017 |
Source | Alcon Research |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Alcon Research |
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 |
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