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
  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 Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Study of DE-105 Ophthalmic Solution in Patients With Persistent Corneal Epithelial Defect

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

Primary Outcome Measures:
  • Restoration of corneal epithelial defect [ Time Frame: Every week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Visual acuity,etc. [ Time Frame: Exit visit,etc. ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00988494

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

No publications provided

ClinicalTrials.gov Identifier: NCT00988494     History of Changes
Other Study ID Numbers: 01050807
Study First Received: September 30, 2009
Last Updated: November 21, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

ClinicalTrials.gov processed this record on July 22, 2014