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NCT00586625 Clinical Trial

Safety Study for Bepotastine Besilate Ophthalmic Solution in Normal Volunteers

Allergic Conjunctivitis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00586625
Other study ID # CL-SAF-0405071-P
Secondary ID
Status Completed
Phase Phase 3
First received December 21, 2007
Last updated February 13, 2013
Start date October 2007

Study information
Verified date February 2013
Source Bausch & Lomb Incorporated
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

Safety study for bepotastine besilate ophthalmic solution in normal volunteers

Recruitment information / eligibility
Status Completed
Enrollment 861
Est. completion date
Est. primary completion date May 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 3 Years and older
Eligibility Inclusion Criteria:

- Subjects must be at least 3 years of age, and have ocular health within normal limits

Exclusion Criteria:

- No active ocular disease

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Bepreve
One drop, both eyes, twice a day
• Placebo
One drop, both eyes, twice a day

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Bausch & Lomb Incorporated

Outcome
Type Measure Description Time frame Safety issue
Primary 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		 Day 8 & Day 22 Yes
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