NCT00988494

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

September 30, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 2, 2009

Completed
Last Updated

November 22, 2012

Status Verified

November 1, 2012

First QC Date

September 30, 2009

Last Update Submit

November 21, 2012

Conditions

Persistent Corneal Epithelial Defect

Outcome Measures

Primary Outcomes (1)

  • Restoration of corneal epithelial defect

    Every week

Secondary Outcomes (1)

  • Visual acuity,etc.

    Exit visit,etc.

Study Arms (3)

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

DE-105 ophthalmic solutionDRUG

Topical ocular application

High concentration
Placebo ophthalmic solutionDRUG

Topical ocular application

Placebo

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Has corneal epithelial defect and decreased corneal sensitivity.
  • Has undergone continuous treatment for corneal epithelial defect for 1 week or longer.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Santen study sites

Osaka, Japan

Location

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 30, 2009

First Posted

October 2, 2009

Study Start

September 1, 2009

Last Updated

November 22, 2012

Record last verified: 2012-11

Locations

JP(1)