Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2025-12-25 @ 8:55 PM
Study NCT ID:
NCT01616056
Status:
COMPLETED
Last Update Posted:
2017-07-17
First Post:
2012-06-06
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Bandage Lenses in Treating Patients With Ocular Graft-Versus-Host Disease
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Study Overview
Official Title:
A Single Center Phase II Study of Bandage Lenses for Ocular Graft-Versus-Host Disease After Allogeneic Hematopoietic Cell Transplantation
Status:
COMPLETED
Status Verified Date:
2017-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II clinical trial studies how well bandage lenses work in treating patients with ocular graft versus host disease. Bandage lenses may be helpful in relieving eye symptoms and damage caused by eye graft versus host disease.
Detailed Description:
PRIMARY OBJECTIVES:
I. To determine the symptom improvement after 2 weeks of therapy with bandage lenses.
SECONDARY OBJECTIVES:
I. To confirm short-term safety within 1 month after bandage lenses.
II. To determine improvement in ophthalmologic examinations after bandage lenses.
III. To explore the use of optical coherence tomography as an objective measure of corneal inflammation.
OUTLINE:
Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity.
I. To determine the symptom improvement after 2 weeks of therapy with bandage lenses.
SECONDARY OBJECTIVES:
I. To confirm short-term safety within 1 month after bandage lenses.
II. To determine improvement in ophthalmologic examinations after bandage lenses.
III. To explore the use of optical coherence tomography as an objective measure of corneal inflammation.
OUTLINE:
Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2012-00862 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| 2617.00 | OTHER | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | View | |
| P30CA015704 | NIH | None | https://reporter.nih.gov/quic… | View |