Efficacy and Safety Study of Bepotastine Besilate Ophthalmic Solution in Allergic Conjunctivitis - Full Text View

Efficacy and Safety Study of Bepotastine Besilate Ophthalmic Solution in Allergic Conjunctivitis

This study is currently recruiting participants.
Verified by ISTA Pharmaceuticals, December 2007

Sponsored by:	ISTA Pharmaceuticals
Information provided by:	ISTA Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00586664

Purpose

Efficacy and safety study of bepotastine besilate ophthalmic solution in allergic conjunctivitis

Condition	Intervention	Phase
Allergic Conjunctivitis	Drug: bepotastine besilate ophthalmic solution Drug: placebo comparator	Phase III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment

Further study details as provided by ISTA Pharmaceuticals:

Primary Outcome Measures:

Ocular itching and conjunctival redness [ Time Frame: 8 & 16 hours ] [ Designated as safety issue: No ]

Estimated Enrollment:	130
Study Start Date:	October 2007
Estimated Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: bepotastine besilate ophthalmic solution sterile ophthalmic solution
2: Experimental	Drug: bepotastine besilate ophthalmic solution sterile ophthalmic solution
3: Placebo Comparator	Drug: placebo comparator sterile ophthalmic solution

Eligibility

Ages Eligible for Study:	10 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects must be at least 10 years of age

Exclusion Criteria:

No active ocular disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00586664

Contacts


Contact: Tim McNamara, PharmD	949-788-6000	tmcnamara@istavision.com

Locations


United States, California
	ISTA Pharmaceuticals, Inc.	Recruiting
	Irvine, California, United States, 92618
	Contact: Tim McNamara, PharmD 949-788-6000 tmcnamara@istavision.com

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-S&E-0409071-P
First Received:	December 21, 2007
Last Updated:	December 21, 2007
ClinicalTrials.gov Identifier:	NCT00586664
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 October 03, 2008