Back to resultsSafety Study for Bepotastine Besilate Ophthalmic Solution in Normal Volunteers
Primary Purpose
Allergic Conjunctivitis
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Bepreve
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Conjunctivitis
Eligibility Criteria
Inclusion Criteria:
- Subjects must be at least 3 years of age, and have ocular health within normal limits
Exclusion Criteria:
- No active ocular disease
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Bepreve
Placebo
Arm Description
bepotastine besilate ophthalmic solution 1.5%
vehicle
Outcomes
Primary Outcome Measures
Ocular Comfort
A 4-step grading scale with half unit (1-step) increments allowed:
0=Comfortable;discomfort absent; 1.0=Generally comfortable; mild discomfort; 2.0=Some discomfort but tolerable; moderate comfort; 3.0=Severely uncomfortable or intolerable
Secondary Outcome Measures
Full Information
NCT ID
NCT00586625
First Posted
December 21, 2007
Last Updated
February 13, 2013
Sponsor
Bausch & Lomb Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT00586625
Brief Title
Safety Study for Bepotastine Besilate Ophthalmic Solution in Normal Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch & Lomb Incorporated
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Safety study for bepotastine besilate ophthalmic solution in normal volunteers
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Conjunctivitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
861 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bepreve
Arm Type
Experimental
Arm Description
bepotastine besilate ophthalmic solution 1.5%
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
vehicle
Intervention Type
Drug
Intervention Name(s)
Bepreve
Intervention Description
One drop, both eyes, twice a day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
One drop, both eyes, twice a day
Primary Outcome Measure Information:
Title
Ocular Comfort
Description
A 4-step grading scale with half unit (1-step) increments allowed:
0=Comfortable;discomfort absent; 1.0=Generally comfortable; mild discomfort; 2.0=Some discomfort but tolerable; moderate comfort; 3.0=Severely uncomfortable or intolerable
Time Frame
Day 8 & Day 22
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects must be at least 3 years of age, and have ocular health within normal limits
Exclusion Criteria:
No active ocular disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tim McNamara, PharmD
Organizational Affiliation
ISTA Pharmaceuticals, Inc.
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Safety Study for Bepotastine Besilate Ophthalmic Solution in Normal Volunteers
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