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Comparing Patient Satisfaction With Pataday or Bepreve

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
McCabe Vision Center
ClinicalTrials.gov Identifier:
NCT01450176
First received: October 7, 2011
Last updated: January 8, 2014
Last verified: January 2014
  Purpose

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 Intervention
Eye Allergies
Drug: Olopatadine hydrochloride 0.2%
Drug: Bepotastine besilate ophthalmic solution 1.5%

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by McCabe Vision Center:

Primary Outcome Measures:
  • Relief of ocular itching [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
    All day relief of ocular itching throughout the treatment period.


Secondary Outcome Measures:
  • Patient preference [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
    Patient satisfaction, preference, and comfort with treatment


Enrollment: 30
Study Start Date: September 2011
Study Completion Date: December 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01450176

Locations
United States, Tennessee
McCabe Vision Center
Murfreesboro, Tennessee, United States, 37129
Sponsors and Collaborators
McCabe Vision Center
  More Information

No publications provided

Responsible Party: McCabe Vision Center
ClinicalTrials.gov Identifier: NCT01450176     History of Changes
Other Study ID Numbers: MAC-04-11, 3776-001
Study First Received: October 7, 2011
Last Updated: January 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by McCabe Vision Center:
eye
itching
allergies

Additional relevant MeSH terms:
Olopatadine
Ophthalmic Solutions
Pharmaceutical Solutions
Analgesics
Analgesics, Non-Narcotic
Anti-Allergic Agents
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Histamine Agents
Histamine Antagonists
Histamine H1 Antagonists
Histamine H1 Antagonists, Non-Sedating
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014