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Safety Study for Bepotastine Besilate Ophthalmic Solution in Normal Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00586625
Recruitment Status : Completed
First Posted : January 4, 2008
Results First Posted : November 11, 2009
Last Update Posted : February 15, 2013
Information provided by (Responsible Party):

Study Description
Brief Summary:
Safety study for bepotastine besilate ophthalmic solution in normal volunteers

Condition or disease Intervention/treatment Phase
Allergic Conjunctivitis Drug: Bepreve Drug: Placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 861 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : October 2007
Primary Completion Date : May 2008

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Arm Intervention/treatment
Experimental: Bepreve
bepotastine besilate ophthalmic solution 1.5%
Drug: Bepreve
One drop, both eyes, twice a day
Placebo Comparator: Placebo
Drug: Placebo
One drop, both eyes, twice a day

Outcome Measures

Primary Outcome Measures :
  1. Ocular Comfort [ Time Frame: Day 8 & Day 22 ]

    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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00586625

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

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00586625     History of Changes
Other Study ID Numbers: CL-SAF-0405071-P
First Posted: January 4, 2008    Key Record Dates
Results First Posted: November 11, 2009
Last Update Posted: February 15, 2013
Last Verified: February 2013

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