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

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: NCT01337557
Recruitment Status : Unknown
Verified April 2011 by Hom, Milton M., OD, FAAO.
Recruitment status was:  Enrolling by invitation
First Posted : April 19, 2011
Last Update Posted : April 19, 2011
Bausch & Lomb Incorporated
Information provided by:
Hom, Milton M., OD, FAAO

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.

Condition or disease Intervention/treatment Phase
Allergic Conjunctivitis Drug: Bepotastine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Use of BEPREVE (Bepotastine Besilate Ophthalmic Solution) 1.5% for Allergic Conjunctivitis and Contact Lenses
Study Start Date : May 2011
Estimated Primary Completion Date : September 2011
Estimated Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear Pinkeye
Drug Information available for: Bepotastine

Arm Intervention/treatment
Experimental: Bepotastine Drug: Bepotastine
1.5% bid
Other Name: Bepreve

Primary Outcome Measures :
  1. Questionnaire [ Time Frame: 8 weeks ]
    Contact lens comfort and wearing times (measured in hours)

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:   Yes

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.

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): NCT01337557

Sponsors and Collaborators
Hom, Milton M., OD, FAAO
Bausch & Lomb Incorporated
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Principal Investigator: Milton M Hom, OD FAAO Private Practice
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Responsible Party: Milton M. Hom, OD, FAAO., Private Practice Identifier: NCT01337557    
Other Study ID Numbers: MAC-03-11
First Posted: April 19, 2011    Key Record Dates
Last Update Posted: April 19, 2011
Last Verified: April 2011
Keywords provided by Hom, Milton M., OD, FAAO:
Allergic conjunctivitis
Additional relevant MeSH terms:
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Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Immune System Diseases
Bepotastine besilate
Anti-Allergic Agents