Study of Rebamipide Eye Drops to Treat Dry Eye

This study has been completed.

Sponsor:

Collaborator:

Novartis

Information provided by:

Otsuka Pharmaceutical Development & Commercialization, Inc.

ClinicalTrials.gov Identifier:

NCT00201955

First received: September 12, 2005

Last updated: October 31, 2006

Last verified: October 2006

History of Changes

Tracking Information
First Received Date ^ICMJE	September 12, 2005
Last Updated Date	October 31, 2006
Start Date ^ICMJE	May 2004
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: September 12, 2005)	fluorescein corneal staining (FCS) total score at week 12 and the average primary ocular discomfort (POD) severity score at week 12
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00201955 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 12, 2005)	fluorescein corneal staining (FCS) total score at week 26 and the average primary ocular discomfort (POD) severity score at week 26
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Study of Rebamipide Eye Drops to Treat Dry Eye
Official Title ^ICMJE	Rebamipide Ophthalmic Suspension in the Treatment of Dry Eye: A Multicenter, Phase 3, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group, 26 Week Study
Brief Summary	The purpose of this study is to determine the potential safety and effectiveness of rebamipide eye drops, an investigational eye drop being developed for the treatment of keratoconjunctivitis sicca (dry eye).
Detailed Description	There is a need for effective therapy for dry eye that treats the underlying cause of the syndrome. The goal of this study is to assess the impact of rebamipide on dry eye symptoms.
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Condition ^ICMJE	Keratoconjunctivitis Sicca
Intervention ^ICMJE	Drug: Rebamipide
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	740
Completion Date	July 2006
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	Inclusion Criteria: must have symptoms of dry eye for a minimum of 6 months must be able to sign and date an informed consent Exclusion Criteria: presence of anterior segment disease glaucoma or ocular hypertension using Restasis use of topically instilled ocular medications during study use of contact lenses history of ocular surgery within 12 months females who are pregnant, breast feeding, or child-bearing potential and not willing to remain abstinent or use contraception presence of Stevens-Johnson syndrome any anticipated change in medication through-out study concurrent involvement in another study or previous receipt of this drug cannot be safely be weaned off of ocular medications
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00201955
Other Study ID Numbers ^ICMJE	37E-03-201
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators ^ICMJE	Novartis
Investigators ^ICMJE	Not Provided
Information Provided By	Otsuka Pharmaceutical Development & Commercialization, Inc.
Verification Date	October 2006
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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