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Completed

NCT Number: NCT01450176

Comparing Patient Satisfaction With Pataday or Bepreve

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McCabe Vision Center

Murfreesboro, Tennessee, 37129, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Olopatadine hydrochloride 0.2%

Drug

1 drop in each eye once daily for 2 weeks

Other names: Pataday

Bepotastine besilate ophthalmic solution 1.5%

Drug

1 drop in each eye twice daily for 2 weeks

Other names: Bepreve

Primary outcomes

  1. Relief of ocular itching

    Time frame: 5 weeks

    All day relief of ocular itching throughout the treatment period.

Secondary outcomes

  1. Patient preference

    Time frame: 5 weeks

    Patient satisfaction, preference, and comfort with treatment

Sponsors and collaborators

Lead sponsor

McCabe Vision Center

Other

Registry information

Official study title

Comparing Patient Satisfaction Throughout the Day With PATADAY (OLOPATADINE HYDROCHLORIDE) 0.2% QD or BEPREVE (BEPOTASTINE BESILATE OPHTHALMIC SOLUTION) 1.5% BID

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Oct 12, 2011
Registry last updated
Jan 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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