Late Phase 2 Study of OPC-12759 Ophthalmic Suspension - Full Text View

Sponsored by:	Otsuka Pharmaceutical Co., Ltd.
Information provided by:	Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:	NCT00475319

Purpose

The purpose of this study is to evaluate the dose-response of OPC-12759 suspension in dry eye patients

Condition	Intervention	Phase
Dry Eye Syndromes	Drug: OPC-12759	Phase II

Drug Information available for: Rebamipide

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	Late Phase 2 Study of OPC-12759 Ophthalmic Suspension

Further study details as provided by Otsuka Pharmaceutical Co., Ltd.:

Primary Outcome Measures:

fluorescein corneal staining total score at week 4 [ Time Frame: 4weeks after treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Lisamingreen conjunctive staining score at week 4 [ Time Frame: 4weeks after treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	300
Study Start Date:	May 2007
Estimated Study Completion Date:	May 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
P: Placebo Comparator	Drug: OPC-12759 comparison of different dosages of drug
A1: Experimental	Drug: OPC-12759 comparison of different dosages of drug
A2: Experimental	Drug: OPC-12759 comparison of different dosages of drug

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Presence of anterior segment disease or disorder other than that associated with keratoconjunctivitis sicca
Ocular hypertension patient or glaucoma patient with ophthalmic solution
Anticipated use of any topically-instilled ocular medications or patients who cannot discontinue the use during the study
Anticipated use of contact lens during the study
Patient with punctal plug
Any history of ocular surgery within 12 months
Female patients who are pregnant, possibly pregnant or breast feeding
Known hypersensitivity to any component of the study drug or procedural medications
Receipt of any investigational product within 4 months

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00475319

Locations

Sponsors and Collaborators

Otsuka Pharmaceutical Co., Ltd.

Investigators

Study Director:

Satoshi Oshima

Division of dermatologicals and ophthalmologicals

More Information

Responsible Party:	Otsuka Pharmaceutical Co., Ltd. ( Division director )
Study ID Numbers:	037E-06-001
Study First Received:	May 16, 2007
Last Updated:	March 11, 2008
ClinicalTrials.gov Identifier:	NCT00475319
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Otsuka Pharmaceutical Co., Ltd.:

Dry Eye Syndromes
OPC-12759

Study placed in the following topic categories:

Eye Diseases
Lacrimal Apparatus Diseases
Dry Eye Syndromes
Rebamipide

Additional relevant MeSH terms:

Antioxidants
Pathologic Processes
Disease
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Syndrome

Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Protective Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009