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Comparing Patient Satisfaction With Pataday or Bepreve

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01450176
Recruitment Status : Completed
First Posted : October 12, 2011
Last Update Posted : January 9, 2014
Information provided by (Responsible Party):
McCabe Vision Center

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).

Condition or disease Intervention/treatment Phase
Eye Allergies Drug: Olopatadine hydrochloride 0.2% Drug: Bepotastine besilate ophthalmic solution 1.5% Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2011
Actual Primary Completion Date : October 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Pataday once daily
15 subjects will administer Pataday once daily for 2 weeks. Then these subjects will administer Bepreve twice daily for 2 weeks.
Drug: Olopatadine hydrochloride 0.2%
1 drop in each eye once daily for 2 weeks
Other Name: Pataday

Active Comparator: Bepreve twice daily
Bepreve twice daily for 2 weeks, then subjects will use Pataday once daily for 2 weeks
Drug: Bepotastine besilate ophthalmic solution 1.5%
1 drop in each eye twice daily for 2 weeks
Other Name: Bepreve

Primary Outcome Measures :
  1. Relief of ocular itching [ Time Frame: 5 weeks ]
    All day relief of ocular itching throughout the treatment period.

Secondary Outcome Measures :
  1. Patient preference [ Time Frame: 5 weeks ]
    Patient satisfaction, preference, and comfort with treatment

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01450176

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United States, Tennessee
McCabe Vision Center
Murfreesboro, Tennessee, United States, 37129
Sponsors and Collaborators
McCabe Vision Center
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Responsible Party: McCabe Vision Center Identifier: NCT01450176    
Other Study ID Numbers: MAC-04-11
3776-001 ( Registry Identifier: Sterling IRB )
First Posted: October 12, 2011    Key Record Dates
Last Update Posted: January 9, 2014
Last Verified: January 2014
Keywords provided by McCabe Vision Center:
Additional relevant MeSH terms:
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Immune System Diseases
Olopatadine Hydrochloride
Bepotastine besilate
Ophthalmic Solutions
Pharmaceutical Solutions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action