Study of DE-105 Ophthalmic Solution in Patients With Persistent Corneal Epithelial Defect

This study has been completed.

Sponsor:

Information provided by:

Santen Pharmaceutical Co., Ltd.

ClinicalTrials.gov Identifier:

NCT00988494

First received: September 30, 2009

Last updated: November 21, 2012

Last verified: November 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	September 30, 2009
Last Updated Date	November 21, 2012
Start Date ^ICMJE	September 2009
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: November 23, 2009)	Restoration of corneal epithelial defect [ Time Frame: Every week ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00988494 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: November 23, 2009)	Visual acuity,etc. [ Time Frame: Exit visit,etc. ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Study of DE-105 Ophthalmic Solution in Patients With Persistent Corneal Epithelial Defect
Official Title ^ICMJE	Study of DE-105 Ophthalmic Solution in Patients With Persistent Corneal Epithelial Defect
Brief Summary	Safety and efficacy of DE-105 ophthalmic solution in patients with persistent corneal epithelial defect will be evaluated. Dose-dependent efficacy will be evaluated as well.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Persistent Corneal Epithelial Defect
Intervention ^ICMJE	Drug: DE-105 ophthalmic solution Topical ocular application Drug: Placebo ophthalmic solution Topical ocular application
Study Arm (s)	Experimental: High concentration DE-105 high concentration Intervention: Drug: DE-105 ophthalmic solution Experimental: Low concentration DE-105 low concentration Intervention: Drug: DE-105 ophthalmic solution Placebo Comparator: Placebo DE-105 placebo Intervention: Drug: Placebo ophthalmic solution
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
Estimated Enrollment ^ICMJE	45
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	Inclusion Criteria: Has corneal epithelial defect and decreased corneal sensitivity. Has undergone continuous treatment for corneal epithelial defect for 1 week or longer. Exclusion Criteria: Presence of disease such as active ocular infection, or abnormal lid closure. History or presence of chemical burn, Stevens - Johnson Syndrome, etc. History of corneal transplantation, LASIK, or hematopoietic stem cell transplantation.
Gender	Both
Ages	12 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Japan

Administrative Information
NCT Number ^ICMJE	NCT00988494
Other Study ID Numbers ^ICMJE	01050807
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Santen Pharmaceutical Co., Ltd.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Santen Pharmaceutical Co., Ltd.
Verification Date	November 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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