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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

September 30, 2009
November 21, 2012
September 2009
Not Provided
Restoration of corneal epithelial defect [ Time Frame: Every week ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00988494 on ClinicalTrials.gov Archive Site
Visual acuity,etc. [ Time Frame: Exit visit,etc. ] [ Designated as safety issue: No ]
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 Blind (Subject, 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.
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00988494
01050807
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