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Comparing Patient Satisfaction With Pataday or Bepreve

Primary Purpose

Eye Allergies

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Olopatadine hydrochloride 0.2%
Bepotastine besilate ophthalmic solution 1.5%
Sponsored by
McCabe Vision Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eye Allergies focused on measuring eye, itching, allergies

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • McCabe Vision Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Pataday once daily

Bepreve twice daily

Arm Description

15 subjects will administer Pataday once daily for 2 weeks. Then these subjects will administer Bepreve twice daily for 2 weeks.

Bepreve twice daily for 2 weeks, then subjects will use Pataday once daily for 2 weeks

Outcomes

Primary Outcome Measures

Relief of ocular itching
All day relief of ocular itching throughout the treatment period.

Secondary Outcome Measures

Patient preference
Patient satisfaction, preference, and comfort with treatment

Full Information

First Posted
October 7, 2011
Last Updated
January 8, 2014
Sponsor
McCabe Vision Center
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1. Study Identification

Unique Protocol Identification Number
NCT01450176
Brief Title
Comparing Patient Satisfaction With Pataday or Bepreve
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 Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McCabe Vision Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eye Allergies
Keywords
eye, itching, allergies

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pataday once daily
Arm Type
Active Comparator
Arm Description
15 subjects will administer Pataday once daily for 2 weeks. Then these subjects will administer Bepreve twice daily for 2 weeks.
Arm Title
Bepreve twice daily
Arm Type
Active Comparator
Arm Description
Bepreve twice daily for 2 weeks, then subjects will use Pataday once daily for 2 weeks
Intervention Type
Drug
Intervention Name(s)
Olopatadine hydrochloride 0.2%
Other Intervention Name(s)
Pataday
Intervention Description
1 drop in each eye once daily for 2 weeks
Intervention Type
Drug
Intervention Name(s)
Bepotastine besilate ophthalmic solution 1.5%
Other Intervention Name(s)
Bepreve
Intervention Description
1 drop in each eye twice daily for 2 weeks
Primary Outcome Measure Information:
Title
Relief of ocular itching
Description
All day relief of ocular itching throughout the treatment period.
Time Frame
5 weeks
Secondary Outcome Measure Information:
Title
Patient preference
Description
Patient satisfaction, preference, and comfort with treatment
Time Frame
5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
McCabe Vision Center
City
Murfreesboro
State/Province
Tennessee
ZIP/Postal Code
37129
Country
United States

12. IPD Sharing Statement

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Comparing Patient Satisfaction With Pataday or Bepreve

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