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

NCT01337557 | Unknown Phase 4

• 1 other identifier: MAC-03-11
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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

Keywords

Allergic conjunctivitis

Outcome Measures

Primary Outcomes (1)

• Questionnaire

  Contact lens comfort and wearing times (measured in hours)

  8 weeks

Study Arms (1)

Bepotastine

EXPERIMENTAL

Drug: Bepotastine

Interventions

Bepotastine DRUG

1.5% bid

Also known as: Bepreve

Bepotastine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hom, Milton M., OD, FAAO: lead
• Bausch & Lomb Incorporated: collaborator

MeSH Terms

Conditions

Conjunctivitis, Allergic

Interventions

bepotastine; bepotastine besilate

Condition Hierarchy (Ancestors)

Conjunctivitis; Conjunctival Diseases; Eye Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Milton M Hom, OD FAAO

  Private Practice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDIV

Study Record Dates

• First Submitted: April 14, 2011
• First Posted: April 19, 2011
• Study Start: May 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: November 1, 2011
• Last Updated: April 19, 2011

Record last verified: 2011-04