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

Allergic Conjunctivitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01337557
• Other study ID #: MAC-03-11
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: April 14, 2011
• Last updated: April 18, 2011
• Start date: May 2011
• Est. completion date: November 2011

Study information

• Verified date: April 2011
• Source: Hom, Milton M., OD, FAAO
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 24
• Est. completion date: November 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Conjunctivitis
• Conjunctivitis
• Conjunctivitis, Allergic

Intervention

Drug:
• Bepotastine
1.5% bid

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Hom, Milton M., OD, FAAO	Bausch & Lomb Incorporated

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Questionnaire	Contact lens comfort and wearing times (measured in hours)	8 weeks	No