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Safety Study for Bepotastine Besilate Ophthalmic Solution in Normal Volunteers
This study has been completed.
Sponsored by: ISTA Pharmaceuticals
Information provided by: ISTA Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00586625
  Purpose

Safety study for bepotastine besilate ophthalmic solution in normal volunteers


Condition Intervention
Allergic Conjunctivitis
Drug: bepotastine besilate ophthalmic solution

U.S. FDA Resources
Study Type: Observational
Study Design: Prospective

Further study details as provided by ISTA Pharmaceuticals:

Primary Outcome Measures:
  • Safety and tolerability [ Designated as safety issue: Yes ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 850
Study Start Date: October 2007
  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00586625

Sponsors and Collaborators
ISTA Pharmaceuticals
Investigators
Study Director: Tim McNamara, PharmD ISTA Pharmaceuticals, Inc.
  More Information

Responsible Party: ISTA Pharmaceuticals, Inc. ( Tim McNamara, Vice President Clinical Research & Medical Affairs )
Study ID Numbers: CL-SAF-0405071-P
Study First Received: December 21, 2007
Last Updated: December 21, 2007
ClinicalTrials.gov Identifier: NCT00586625  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Hypersensitivity
Conjunctivitis, Allergic
Eye Diseases
Hypersensitivity, Immediate
Conjunctivitis
Conjunctival Diseases

Additional relevant MeSH terms:
Immune System Diseases

ClinicalTrials.gov processed this record on January 14, 2009