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

NCT ID: NCT01337557

Last Updated: 2011-04-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2011-11-30

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.

Conditions

Allergic Conjunctivitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Bepotastine

Group Type: EXPERIMENTAL

Bepotastine

Intervention Type: DRUG

1.5% bid

Interventions

Bepotastine

1.5% bid

Intervention Type: DRUG

Other Intervention Names

Bepreve

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role: collaborator

Hom, Milton M., OD, FAAO

INDIV

Sponsor Role: lead

Responsible Party

Private Practice

Principal Investigators

Milton M Hom, OD FAAO

Role: PRINCIPAL_INVESTIGATOR

Private Practice

Other Identifiers

MAC-03-11

Identifier Type: -

Identifier Source: org_study_id