Confirmatory Study of OPC-12759 Ophthalmic Suspension

This study is currently recruiting participants.

Verified by Otsuka Pharmaceutical Co., Ltd., April 2009

First Received: April 19, 2009 Last Updated: May 12, 2009 History of Changes

Sponsored by:	Otsuka Pharmaceutical Co., Ltd.
Information provided by:	Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:	NCT00885079

Purpose

The purpose of this study is to verify whether OPC-12759 ophthalmic suspension is effective compared with active control in dry eye patients.

Condition	Intervention	Phase
Dry Eye Syndromes	Drug: OPC-12759 Ophthalmic suspension Drug: Hyalein Mini Ophthalmic solution	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Confirmatory Study of OPC-12759 Ophthalmic Suspension in Dry Eye Patients

Resource links provided by NLM:

Drug Information available for: Rebamipide

U.S. FDA Resources

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

Primary Outcome Measures:

Fluorescein corneal staining score and Lisamingreen conjunctive staining score [ Time Frame: Weeks2, 4 ] [ Designated as safety issue: No ]

Estimated Enrollment:	180
Study Start Date:	May 2009
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1.: Experimental Instillation,4 times/day for 4 weeks	Drug: OPC-12759 Ophthalmic suspension OPC-12759 Ophthalmic suspension 2%
2.: Active Comparator Instillation,6 times/day for 4 weeks	Drug: Hyalein Mini Ophthalmic solution Hyalein Mini Ophthalmic solution 0.1%

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Out patient
Subjective complaint of dry eye that has been present for minimum 20 months
Ocular discomfort severity is moderate to severe
Corneal - conjunctival damage is moderate to severe
Unanesthetized Schirmer's test score of 5mm/5minutes or less
Best corrected visual acuity of 0.2 or better in both eyes

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: NCT00885079

Contacts

Contact: Drug Information Center

opc_ctr@otsuka.jp

Locations

Japan
Kanto region	Recruiting
Tokyo, Japan
Tokai region	Recruiting
Nagoya, Japan
Kansai region	Recruiting
Osaka, Japan
Chushikoku region	Recruiting
Matsuyama, Japan
Kyushu region	Recruiting
Kagoshima, Japan

Sponsors and Collaborators

Otsuka Pharmaceutical Co., Ltd.

Investigators

Study Chair:

Eiji Murakami

OPCJ-DDO

More Information

No publications provided

Responsible Party:	Otsuka Pharmaceutical Co., Ltd. ( Eiji Murakami/Director of Division of Dermatologicals and Ophthalmologicals )
Study ID Numbers:	037E-08-001
Study First Received:	April 19, 2009
Last Updated:	May 12, 2009
ClinicalTrials.gov Identifier:	NCT00885079 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare; Japan: Pharmaceuticals and Medical Devices Agency

Study placed in the following topic categories:

Antioxidants
Eye Diseases
Lacrimal Apparatus Diseases
Dry Eye Syndromes
Rebamipide

Additional relevant MeSH terms:

Disease
Antioxidants
Molecular Mechanisms of Pharmacological Action
Eye Diseases
Physiological Effects of Drugs
Gastrointestinal Agents
Lacrimal Apparatus Diseases
Enzyme Inhibitors

Dry Eye Syndromes
Protective Agents
Rebamipide
Pharmacologic Actions
Pathologic Processes
Syndrome
Therapeutic Uses
Anti-Ulcer Agents

ClinicalTrials.gov processed this record on August 24, 2009