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Comparing Patient Satisfaction With Pataday or Bepreve

Information source: McCabe Vision Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Eye Allergies

Intervention: Olopatadine hydrochloride 0.2% (Drug); Bepotastine besilate ophthalmic solution 1.5% (Drug)

Phase: N/A

Status: Completed

Sponsored by: McCabe Vision Center


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).

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Relief of ocular itching

Secondary outcome: Patient preference

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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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.

Locations and Contacts

McCabe Vision Center, Murfreesboro, Tennessee 37129, United States
Additional Information

Starting date: September 2011
Last updated: January 8, 2014

Page last updated: August 23, 2015

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