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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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00988494
Enrollment
45
Registered
2009-10-02
Start date
2009-09-30
Completion date
Unknown
Last updated
2012-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Persistent Corneal Epithelial Defect

Brief summary

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.

Interventions

DRUGDE-105 ophthalmic solution

Topical ocular application

DRUGPlacebo ophthalmic solution

Topical ocular application

Sponsors

Santen Pharmaceutical Co., Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Restoration of corneal epithelial defectEvery week

Secondary

MeasureTime frame
Visual acuity,etc.Exit visit,etc.

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026