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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00988494
First Posted: October 2, 2009
Last Update Posted: November 22, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Santen Pharmaceutical Co., Ltd.
September 30, 2009
October 2, 2009
November 22, 2012
September 2009
Not Provided
Restoration of corneal epithelial defect [ Time Frame: Every week ]
Not Provided
Complete list of historical versions of study NCT00988494 on ClinicalTrials.gov Archive Site
Visual acuity,etc. [ Time Frame: Exit visit,etc. ]
Not Provided
Not Provided
Not Provided
 
Study of DE-105 Ophthalmic Solution in Patients With Persistent Corneal Epithelial Defect
Study of DE-105 Ophthalmic Solution in Patients With Persistent Corneal Epithelial Defect
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Persistent Corneal Epithelial Defect
  • Drug: DE-105 ophthalmic solution
    Topical ocular application
  • Drug: Placebo ophthalmic solution
    Topical ocular application
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
Not Provided
Not Provided

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.
Sexes Eligible for Study: All
12 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00988494
01050807
Not Provided
Not Provided
Not Provided
Not Provided
Santen Pharmaceutical Co., Ltd.
Not Provided
Not Provided
Santen Pharmaceutical Co., Ltd.
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP