Long Term Administration Study of OPC-12759 Ophthalmic Suspension - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

January 4, 2009

Last Updated Date

January 5, 2009

Start Date ^†

January 2009

Current Primary Outcome Measures ^†

Fluorescein corneal staining score [ Time Frame: Weeks2,4,8,12,16,20,24,28,32,36,40,44,48,52 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00818324 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Lisamingreen conjunctive staining score [ Time Frame: Weeks2,4,8,12,16,20,24,28,32,36,40,44,48,52 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Long Term Administration Study of OPC-12759 Ophthalmic Suspension

Official Title ^†

Long Term Administration Study of OPC-12759 Ophthalmic Suspension in Dry Eye Patients

Brief Summary

The purpose of this study is to evaluate safety and efficacy of OPC-12759 ophthalmic suspension during 52 weeks in dry eye patients

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^†

Dry Eye Syndromes

Intervention ^†

Drug: OPC-12759 Ophthalmic suspension

Study Arms / Comparison Groups

Experimental: Instillation, 4times/day

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Estimated Enrollment ^†

153

Estimated Completion Date

September 2010

Estimated Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

Out patient;
Ocular discomfort severity is moderate to severe;
Corneal-conjunctival damage is moderate to severe;
Unanesthetized Schirmer's test score of 5mm/5minutes or less,or tear breakup time is 5 seconds 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 scicca;
Ocular hypertention 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 procedual medications;
Receipt of any investigational product within 4 months.

Gender

Both

Ages

20 Years and older

Accepts Healthy Volunteers

Contacts ^††

Contact: Drug Information Center

opc_ctr@otsuka.jp

Location Countries ^†

Japan

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00818324

Responsible Party

Eiji Murakami/Director of Division of Dermatologicals and Ophthalmologicals, Otsuka Pharmaceutical Co., Ltd.

Secondary IDs ^††

Study Sponsor ^†

Otsuka Pharmaceutical Co., Ltd.

Collaborators ^††

Investigators ^†

Study Chair:

Eiji Murakami

OPCJ-DDO

Information Provided By

Otsuka Pharmaceutical Co., Ltd.

Verification Date

January 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.