NCT01450176CompletedNot Applicable
Comparing Patient Satisfaction Throughout the Day With PATADAY (OLOPATADINE HYDROCHLORIDE) 0.2% QD or BEPREVE (BEPOTASTINE BESILATE OPHTHALMIC SOLUTION) 1.5% BID
McCabe Vision Center1 site in 1 country30 target enrollmentStarted: September 2011Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Relief of ocular itching
Study Overview
Brief Summary
The purpose of this study is to compare patient satisfaction with Pataday (Olopatadine hydrochloride 0.2%) one daily (QD) and Bepreve (Bepotastine besilate ophthalmic solution 1.5%) two times a day (BID).
Detailed Description
5 week randomized study with 15 subjects using Pataday qd for 2 weeks, and the other 15 subjects using Bepreve BID for 2 weeks. Following a one-week washout period, the two groups are given the opposite test article (TA) for 2 weeks. Subjects to complete daily diary regarding effects of drug and are seen in clinic for 3 exams.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Be male or female subjects of any racial/ethnic group.
- •Be at least 18 years of age or older.
- •Have a diagnosis of allergic conjunctivitis with active symptoms, with no concurrent ocular allergy associated conditions and no plans to have ocular surgery during study period.
- •Willing and able to return for all required visits and follow instructions from investigator and staff.
- •Able to self-administer test article (TA) or have a caregiver available to instill all doses of TA.
- •If a woman, capable of becoming pregnant, agrees to have pregnancy testing performed at screening (must be negative) and agrees to use a medically acceptable form of birth control (intrauterine device, birth control pill, patch or subcutaneous implant, condoms, diaphragm, and abstinence) throughout the study duration and for at least one week prior to and one week after completion of the study. Women considered capable of becoming pregnant include all females who have experienced menarche and who have not experienced menopause (as defined by amenorrhea for greater than 12 consecutive months) or have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy).
- •Sign and date the informed consent form approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC).
- •Be willing/able to return for all required study visits, to follow instructions from the study investigator and his/her staff, and to complete and return the Screening and Subject Diaries.
Exclusion Criteria
- •Have known hypersensitivity to BEPREVE or PATADAY or any of their components.
- •Are actively taking steroids or antihistamines during the study or within 7 days prior to enrolling in the study.
- •Are pregnant, planning to become pregnant, or nursing/lactating.
- •Have a known history of alcohol or drug abuse.
- •Participated in a study of an investigational drug or device within the past 30 days prior to enrolling in the study.
- •Have a presence of an active ocular infection (bacterial, viral or fungal), positive history of an ocular herpetic infection, or preauricular lymphadenopathy at any visit.
- •Have any significant illness {eg: any autoimmune disease, or severe cardiovascular disease (including arrhythmias)}that the Investigator feels could be expected to interfere with the subject's safety or study parameters and/or put the subject at anyh unnecessary risk.
Arms & Interventions
Pataday once daily
Active Comparator
15 subjects will administer Pataday once daily for 2 weeks. Then these subjects will administer Bepreve twice daily for 2 weeks.
Intervention: Olopatadine hydrochloride 0.2% (Drug)
Bepreve twice daily
Active Comparator
Bepreve twice daily for 2 weeks, then subjects will use Pataday once daily for 2 weeks
Intervention: Bepotastine besilate ophthalmic solution 1.5% (Drug)
Outcomes
Primary Outcomes
Relief of ocular itching
Time Frame: 5 weeks
All day relief of ocular itching throughout the treatment period.
Secondary Outcomes
- Patient preference(5 weeks)
Investigators
Study Sites (1)
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