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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
December 21, 2007
January 4, 2008
October 8, 2009
November 11, 2009
February 15, 2013
October 2007
May 2008   (Final data collection date for primary outcome measure)
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

Safety and tolerability
Complete list of historical versions of study NCT00586625 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Safety Study for Bepotastine Besilate Ophthalmic Solution in Normal Volunteers
Not Provided
Safety study for bepotastine besilate ophthalmic solution in normal volunteers
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Allergic Conjunctivitis
  • Drug: Bepreve
    One drop, both eyes, twice a day
  • Drug: Placebo
    One drop, both eyes, twice a day
  • Experimental: Bepreve
    bepotastine besilate ophthalmic solution 1.5%
    Intervention: Drug: Bepreve
  • Placebo Comparator: Placebo
    vehicle
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
861
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May 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • No active ocular disease
Sexes Eligible for Study: All
3 Years and older   (Child, Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00586625
CL-SAF-0405071-P
No
Not Provided
Not Provided
Bausch & Lomb Incorporated
Bausch & Lomb Incorporated
Not Provided
Study Director: Tim McNamara, PharmD ISTA Pharmaceuticals, Inc.
Bausch & Lomb Incorporated
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP