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Safety Study for Bepotastine Besilate Ophthalmic Solution in Normal Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00586625
First received: December 21, 2007
Last updated: February 13, 2013
Last verified: February 2013
History of Changes
  Purpose

Safety study for bepotastine besilate ophthalmic solution in normal volunteers


Condition Intervention Phase
Allergic Conjunctivitis
 Drug: Bepreve
Drug: Placebo
 Phase 3

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

Resource links provided by NLM:

MedlinePlus related topics: Pinkeye
Drug Information available for: Bepotastine
U.S. FDA Resources

Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Ocular Comfort [ Time Frame: Day 8 & Day 22 ] [ Designated as safety issue: Yes ]

    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



Enrollment: 861
Study Start Date: October 2007
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bepreve
bepotastine besilate ophthalmic solution 1.5%
 Drug: Bepreve
One drop, both eyes, twice a day
Placebo Comparator: Placebo
vehicle
 Drug: Placebo
One drop, both eyes, twice a day

  Eligibility

Ages Eligible for Study:   3 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00586625

Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Study Director: Tim McNamara, PharmD ISTA Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00586625     History of Changes
Other Study ID Numbers: CL-SAF-0405071-P
Study First Received: December 21, 2007
Results First Received: October 8, 2009
Last Updated: February 13, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
 Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 19, 2013