NCT01616056

Bandage Lenses in Treating Patients With Ocular Graft-Versus-Host Disease

A Single Center Phase II Study of Bandage Lenses for Ocular Graft-Versus-Host Disease After Allogeneic Hematopoietic Cell Transplantation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Fred Hutchinson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Graft Versus Host Disease
• Ophthalmologic Complications

Interventions

Type	Name	Description
BIOLOGICAL	graft versus host disease prophylaxis/therapy	Wear bandage lenses
OTHER	questionnaire administration	Ancillary studies
PROCEDURE	optical coherence tomography	Optional ancillary studies

Timeline

• Start date: 2012-06-01
• Primary completion: 2014-10-01
• Completion: 2014-12-01
• First posted: 2012-06-11
• Last updated: 2017-07-17
• Results posted: 2017-07-17

Locations

1 site across 1 country: United States