April 2011
Volume 52, Issue 14
Free
ARVO Annual Meeting Abstract  |   April 2011
The Conjunctival Safety Of Bepotastine Besilate Ophthalmic Solution 1.5% In A Safety Clinical Trial
Author Affiliations & Notes
  • Timothy R. McNamara
    ISTA Pharmaceuticals, Inc., Irvine, California
  • Stacey L. Ackerman
    Clinical Res/Private Practice, Philadelphia Eye Associates, Philadelphia, Pennsylvania
  • Jung T. Dao
    Cornea Consultants of Arizona, Phoenix, Arizona
  • Jon I. Williams
    ISTA Pharmaceuticals, Inc., Irvine, California
  • James A. Gow
    ISTA Pharmaceuticals, Inc., Irvine, California
  • Bepotastine Besilate Ophthalmic Solutions ClinicalStudy Group
    ISTA Pharmaceuticals, Inc., Irvine, California
  • Footnotes
    Commercial Relationships  Timothy R. McNamara, ISTA Pharmaceuticals, Inc. (I, E, R); Stacey L. Ackerman, ISTA Pharmaceuticals, Inc. (C, R); Jung T. Dao, ISTA Pharmaceuticals, Inc. (C, R); Jon I. Williams, ISTA Pharmaceuticals, Inc. (I, E, R); James A. Gow, ISTA Pharmaceuticals, Inc. (I, E, R)
  • Footnotes
    Support  ISTA Pharmaceuticals, Inc.
Investigative Ophthalmology & Visual Science April 2011, Vol.52, 6414. doi:
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      Timothy R. McNamara, Stacey L. Ackerman, Jung T. Dao, Jon I. Williams, James A. Gow, Bepotastine Besilate Ophthalmic Solutions ClinicalStudy Group; The Conjunctival Safety Of Bepotastine Besilate Ophthalmic Solution 1.5% In A Safety Clinical Trial. Invest. Ophthalmol. Vis. Sci. 2011;52(14):6414.

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Abstract

Purpose: : To evaluate the conjunctival safety of bepotastine besilate ophthalmic solution 1.5%, a dual-acting histamine H1 receptor antagonist and mast cell stabilizer, after 6 weeks of twice daily dosing in healthy pediatric and adult subjects.

Methods: : The clinical trial was a multi-center, randomized, double-masked, placebo-controlled, parallel-group, 6-week safety study dosing bilaterally with bepotastine besilate ophthalmic solution 1.5% or placebo and involving 4 clinic visits. Pediatric subjects ≥ 3 years of age were 14.8% (127/861) of total subjects. Compliance was monitored with dosing diaries. Conjunctival (palpebral and bulbar) hyperemia and chemosis were assessed with slit lamp biomicroscopy examinations and graded on a 0-4 scale.

Results: : Bepotastine besilate ophthalmic solution 1.5% subjects had no clinically significant abnormal results compared to placebo. No early withdrawals were due to conjunctival adverse events in the bepotastine besilate ophthalmic solution 1.5% group and no serious adverse events reported.

Conclusions: : Bepotastine besilate ophthalmic solution 1.5% dosed for 6 weeks was safe for the conjunctiva in a healthy pediatric and adult population.

Clinical Trial: : http://www.clinicaltrials.gov NCT00586625

Keywords: conjunctivitis • clinical (human) or epidemiologic studies: outcomes/complications • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials 
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