We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
  Purpose
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.

Condition Intervention Phase
Persistent Corneal Epithelial Defect Drug: DE-105 ophthalmic solution Drug: Placebo ophthalmic solution Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Study of DE-105 Ophthalmic Solution in Patients With Persistent Corneal Epithelial Defect

Resource links provided by NLM:


Further study details as provided by Santen Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • Restoration of corneal epithelial defect [ Time Frame: Every week ]

Secondary Outcome Measures:
  • Visual acuity,etc. [ Time Frame: Exit visit,etc. ]

Estimated Enrollment: 45
Study Start Date: September 2009
Arms Assigned Interventions
Experimental: High concentration
DE-105 high concentration
Drug: DE-105 ophthalmic solution
Topical ocular application
Experimental: Low concentration
DE-105 low concentration
Drug: DE-105 ophthalmic solution
Topical ocular application
Placebo Comparator: Placebo
DE-105 placebo
Drug: Placebo ophthalmic solution
Topical ocular application

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00988494


Locations
Japan
Santen study sites
Osaka, Japan
Sponsors and Collaborators
Santen Pharmaceutical Co., Ltd.
  More Information

ClinicalTrials.gov Identifier: NCT00988494     History of Changes
Other Study ID Numbers: 01050807
First Submitted: September 30, 2009
First Posted: October 2, 2009
Last Update Posted: November 22, 2012
Last Verified: November 2012

Additional relevant MeSH terms:
Pharmaceutical Solutions
Ophthalmic Solutions