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
  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:


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
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, see Learn About Clinical Studies.

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
Ophthalmic Solutions
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014