Comparing Patient Satisfaction With Pataday or Bepreve
Status: | Completed |
---|---|
Conditions: | Neurology |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 1/1/2014 |
Start Date: | September 2011 |
End Date: | December 2011 |
Contact: | HELEN BALDWIN, A.S., C.O.T. |
Email: | helen@mccabevisioncenter.com |
Phone: | 615-904-9024 |
Comparing Patient Satisfaction Throughout the Day With PATADAY (OLOPATADINE HYDROCHLORIDE) 0.2% QD or BEPREVE (BEPOTASTINE BESILATE OPHTHALMIC SOLUTION) 1.5% BID
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).
hydrochloride 0.2%) one daily (QD) and Bepreve (Bepotastine besilate ophthalmic solution
1.5%) two times a day (BID).
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.
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.
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.
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