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Safety Study for Bepotastine Besilate Ophthalmic Solution in Normal Volunteers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00586625
First Posted: January 4, 2008
Last Update Posted: February 15, 2013
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.
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
  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 (Participant, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • 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



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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   3 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
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
Investigators
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 Submitted: December 21, 2007
First Posted: January 4, 2008
Results First Submitted: October 8, 2009
Results First Posted: November 11, 2009
Last Update Posted: February 15, 2013
Last Verified: February 2013

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


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