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

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.

Study Overview

• Status: Unknown
• Conditions: Allergic Conjunctivitis
• Intervention / Treatment: Drug: Bepotastine

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bepotastine	Drug: Bepotastine; 1.5% bid; Other Names: Bepreve

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Questionnaire	Contact lens comfort and wearing times (measured in hours)	8 weeks

Collaborators and Investigators

• Sponsor: Hom, Milton M., OD, FAAO
• Collaborators: Bausch & Lomb Incorporated
• Investigators: Principal Investigator: Milton M Hom, OD FAAO, Private Practice

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Anticipated): September 1, 2011
• Study Completion (Anticipated): November 1, 2011

Study Registration Dates

• First Submitted: April 14, 2011
• First Submitted That Met QC Criteria: April 18, 2011
• First Posted (Estimate): April 19, 2011

Study Record Updates

• Last Update Posted (Estimate): April 19, 2011
• Last Update Submitted That Met QC Criteria: April 18, 2011
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Keywords: Allergic conjunctivitis
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Eye Diseases; Hypersensitivity; Conjunctival Diseases; Conjunctivitis; Conjunctivitis, Allergic; Anti-Allergic Agents; Bepotastine besilate
• Other Study ID Numbers: MAC-03-11