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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
History of Changes
  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
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 May 16, 2013