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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Bausch & Lomb Incorporated
Information provided by:
Hom, Milton M., OD, FAAO
ClinicalTrials.gov Identifier:
NCT01337557
First received: April 14, 2011
Last updated: April 18, 2011
Last verified: April 2011
  Purpose

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 Intervention Phase
Allergic Conjunctivitis
Drug: Bepotastine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Use of BEPREVE (Bepotastine Besilate Ophthalmic Solution) 1.5% for Allergic Conjunctivitis and Contact Lenses

Resource links provided by NLM:


Further study details as provided by Hom, Milton M., OD, FAAO:

Primary Outcome Measures:
  • Questionnaire [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Contact lens comfort and wearing times (measured in hours)


Estimated Enrollment: 24
Study Start Date: May 2011
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bepotastine Drug: Bepotastine
1.5% bid
Other Name: Bepreve

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  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: NCT01337557

Sponsors and Collaborators
Hom, Milton M., OD, FAAO
Bausch & Lomb Incorporated
Investigators
Principal Investigator: Milton M Hom, OD FAAO Private Practice
  More Information

No publications provided

Responsible Party: Milton M. Hom, OD, FAAO., Private Practice
ClinicalTrials.gov Identifier: NCT01337557     History of Changes
Other Study ID Numbers: MAC-03-11
Study First Received: April 14, 2011
Last Updated: April 18, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Hom, Milton M., OD, FAAO:
Allergic conjunctivitis

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Ophthalmic Solutions
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014