Clinical trial NCT01450176: Comparing Patient Satisfaction With Pataday or Bepreve
Official title: Comparing Patient Satisfaction Throughout the Day With PATADAY (OLOPATADINE HYDROCHLORIDE) 0.2% QD or BEPREVE (BEPOTASTINE BESILATE OPHTHALMIC SOLUTION) 1.5% BID
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eye Allergies
Keywords: eye
itching
allergies
Lead sponsor: McCabe Vision Center
Sponsor class: OTHER
First posted: 2011-10-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Relief of ocular itching
timeFrame: 5 weeks
Secondary outcomes:
measure: Patient preference
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Murfreesboro
country: United States
facility: McCabe Vision Center
state: Tennessee
Study officials:
References: