Study of DE-105 Ophthalmic Solution in Patients With Pers... | NCT00988494

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

NCT00988494

Sponsor

Santen Pharmaceutical Co., Ltd.

Status

Completed

Last Update Posted

Nov 22, 2012Estimated

Enrollment

45Estimated

Phase

Phase 2

Conditions

Persistent Corneal Epithelial Defect

Interventions

DE-105 ophthalmic solution
DE-105 ophthalmic solution
Placebo ophthalmic solution

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2009

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 30, 2009

First Submission Date that Met QC Criteria

Oct 1, 2009

First Posted Date

Oct 2, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 21, 2012

Last Update Posted Date

Nov 22, 2012Estimated

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
High concentration	Experimental	DE-105 high concentration	Drug: DE-105 ophthalmic solution
Low concentration	Experimental	DE-105 low concentration	Drug: DE-105 ophthalmic solution
Placebo	Placebo Comparator	DE-105 placebo	Drug: Placebo ophthalmic solution

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DE-105 ophthalmic solution	Drug	Topical ocular application	High concentration

Measure	Description	Time Frame
Restoration of corneal epithelial defect		Every week

Measure	Description	Time Frame
Visual acuity,etc.		Exit visit,etc.

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided