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Use of BEPREVE (Bepotastine Besilate Ophthalmic Solution) 1.5% for Allergic Conjunctivitis and Contact Lenses

Primary Purpose

Allergic Conjunctivitis

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Bepotastine
Sponsored by
Hom, Milton M., OD, FAAO
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Conjunctivitis focused on measuring Allergic conjunctivitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • History of allergic conjunctivitis
  • History of contact lens intolerance
  • Between the ages of 18 and over inclusive.
  • Males or females
  • Patient is in generally good & stable overall health.
  • Patient likely to comply with study guidelines & study visits. Informed consent signed.
  • Are willing/able to return for all required study visits.
  • Are willing/able to follow instructions from the study investigator and his/her staff.
  • If a woman capable of becoming pregnant, agree to have urine pregnancy testing performed at screening (must be negative) and agree to use a medically acceptable form of birth control throughout the study duration and for at least one week prior to and 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).
  • Have signed informed consent approved by Institutional Review Board or Independent Ethics Committee.

Exclusion Criteria:

  • Corneal refractive surgery within 6 months of this study.
  • Current use of Restasis
  • Intra-ocular surgery within 6 months or ocular laser surgery within 6 months.
  • Pregnant or lactating women.
  • Ocular pathology (includes glaucoma and cataract), which could impact results and/or place patient at risk.
  • Systemic or injected corticosteroids (including oral, parenteral, intravenous, rectal) 30 days;
  • Nasal or inhaled or ocular corticosteroids 14 days;
  • Nasal or inhaled ipratropium bromide (or atropine), inhaled nedocromil, or nasal, inhaled, or ophthalmic sodium cromolyn 14 days;
  • Agents with antihistaminic/anticholinergic activity (e.g. antidepressants, antipsychotics) 14 days;
  • Leukotriene pathway modifiers (Accolate, Singulair, Zyflo) 10 days;
  • Ocular anti-allergy medications including lodoxamide (Alomide), olopatadine (Patanol/Pataday), emedastine difumarate (Emadine), epinastine (Elestat), levocabastine (Livostin) 7 days;
  • Non-steroidal anti-inflammatory ophthalmics including bromfenac (Xibrom), ketorolac (Acular/Acuvail), nepafenac (Nevanac), flurbiprofen (Ocufen), suprofen (Profenal), diclofenac (Voltaren) 7 days;
  • OTC ophthalmic decongestant, antihistamine, or decongestant/antihistamine combinations 3 days;
  • Other anticholinergic agents 3 days
  • Immunotherapy injection 1 day.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Bepotastine

    Arm Description

    Outcomes

    Primary Outcome Measures

    Questionnaire
    Contact lens comfort and wearing times (measured in hours)

    Secondary Outcome Measures

    Full Information

    First Posted
    April 14, 2011
    Last Updated
    April 18, 2011
    Sponsor
    Hom, Milton M., OD, FAAO
    Collaborators
    Bausch & Lomb Incorporated
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01337557
    Brief Title
    Use of BEPREVE (Bepotastine Besilate Ophthalmic Solution) 1.5% for Allergic Conjunctivitis and Contact Lenses
    Official Title
    Use of BEPREVE (Bepotastine Besilate Ophthalmic Solution) 1.5% for Allergic Conjunctivitis and Contact Lenses
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2011
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 2011 (undefined)
    Primary Completion Date
    September 2011 (Anticipated)
    Study Completion Date
    November 2011 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Hom, Milton M., OD, FAAO
    Collaborators
    Bausch & Lomb Incorporated

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to assess if BEPREVE (bepotastine besilate ophthalmic solution) 1.5% will have an effect on contact lens wear in patients with contact lens intolerance due to allergic conjunctivitis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Allergic Conjunctivitis
    Keywords
    Allergic conjunctivitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Crossover Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    24 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Bepotastine
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Bepotastine
    Other Intervention Name(s)
    Bepreve
    Intervention Description
    1.5% bid
    Primary Outcome Measure Information:
    Title
    Questionnaire
    Description
    Contact lens comfort and wearing times (measured in hours)
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: History of allergic conjunctivitis History of contact lens intolerance Between the ages of 18 and over inclusive. Males or females Patient is in generally good & stable overall health. Patient likely to comply with study guidelines & study visits. Informed consent signed. Are willing/able to return for all required study visits. Are willing/able to follow instructions from the study investigator and his/her staff. If a woman capable of becoming pregnant, agree to have urine pregnancy testing performed at screening (must be negative) and agree to use a medically acceptable form of birth control throughout the study duration and for at least one week prior to and 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). Have signed informed consent approved by Institutional Review Board or Independent Ethics Committee. Exclusion Criteria: Corneal refractive surgery within 6 months of this study. Current use of Restasis Intra-ocular surgery within 6 months or ocular laser surgery within 6 months. Pregnant or lactating women. Ocular pathology (includes glaucoma and cataract), which could impact results and/or place patient at risk. Systemic or injected corticosteroids (including oral, parenteral, intravenous, rectal) 30 days; Nasal or inhaled or ocular corticosteroids 14 days; Nasal or inhaled ipratropium bromide (or atropine), inhaled nedocromil, or nasal, inhaled, or ophthalmic sodium cromolyn 14 days; Agents with antihistaminic/anticholinergic activity (e.g. antidepressants, antipsychotics) 14 days; Leukotriene pathway modifiers (Accolate, Singulair, Zyflo) 10 days; Ocular anti-allergy medications including lodoxamide (Alomide), olopatadine (Patanol/Pataday), emedastine difumarate (Emadine), epinastine (Elestat), levocabastine (Livostin) 7 days; Non-steroidal anti-inflammatory ophthalmics including bromfenac (Xibrom), ketorolac (Acular/Acuvail), nepafenac (Nevanac), flurbiprofen (Ocufen), suprofen (Profenal), diclofenac (Voltaren) 7 days; OTC ophthalmic decongestant, antihistamine, or decongestant/antihistamine combinations 3 days; Other anticholinergic agents 3 days Immunotherapy injection 1 day.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Milton M Hom, OD FAAO
    Organizational Affiliation
    Private Practice
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Use of BEPREVE (Bepotastine Besilate Ophthalmic Solution) 1.5% for Allergic Conjunctivitis and Contact Lenses

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