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

Phase 4

• Conditions: Allergic Conjunctivitis
• Interventions: Drug: Bepotastine

• Registration Number: NCT01337557
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-04
• Study First Submitted: 2011-04-14
• Study First Submitted QC: 2011-04-18
• Last Update Submitted: 2011-04-18
• Study First Posted: 2011-04-19
• Last Update Posted: 2011-04-19
• Study Start: 2011-05
• Primary Completion: 2011-09
• Study Completion: 2011-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Bepotastine	Bepotastine	-

Primary Outcome Measures

Name	Time	Method
Questionnaire	8 weeks	Contact lens comfort and wearing times (measured in hours)