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

December 21, 2007
February 13, 2013
October 2007
May 2008   (final data collection date for primary outcome measure)
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

Safety and tolerability [ Designated as safety issue: Yes ]
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 Blind (Subject, 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
Not Provided
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
Both
3 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00586625
CL-SAF-0405071-P
No
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