Use of BEPREVE (Bepotastine Besilate Ophthalmic Solution) 1.5% for Allergic Conjunctivitis and Contact Lenses
Primary Purpose
Allergic Conjunctivitis
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Bepotastine
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Conjunctivitis focused on measuring Allergic conjunctivitis
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Bepotastine
Arm Description
Outcomes
Primary Outcome Measures
Questionnaire
Contact lens comfort and wearing times (measured in hours)
Secondary Outcome Measures
Full Information
NCT ID
NCT01337557
First Posted
April 14, 2011
Last Updated
April 18, 2011
Sponsor
Hom, Milton M., OD, FAAO
Collaborators
Bausch & Lomb Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT01337557
Brief Title
Use of BEPREVE (Bepotastine Besilate Ophthalmic Solution) 1.5% for Allergic Conjunctivitis and Contact Lenses
Official Title
Use of BEPREVE (Bepotastine Besilate Ophthalmic Solution) 1.5% for Allergic Conjunctivitis and Contact Lenses
Study Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Unknown status
Study Start Date
May 2011 (undefined)
Primary Completion Date
September 2011 (Anticipated)
Study Completion Date
November 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Hom, Milton M., OD, FAAO
Collaborators
Bausch & Lomb Incorporated
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Conjunctivitis
Keywords
Allergic conjunctivitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bepotastine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Bepotastine
Other Intervention Name(s)
Bepreve
Intervention Description
1.5% bid
Primary Outcome Measure Information:
Title
Questionnaire
Description
Contact lens comfort and wearing times (measured in hours)
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Milton M Hom, OD FAAO
Organizational Affiliation
Private Practice
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Use of BEPREVE (Bepotastine Besilate Ophthalmic Solution) 1.5% for Allergic Conjunctivitis and Contact Lenses
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