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

Fred Hutchinson Cancer Center (FHCC)

Status and phase

Completed

Phase 2

Conditions

Graft Versus Host Disease

Ophthalmologic Complications

Treatments

Procedure: optical coherence tomography

Other: questionnaire administration

Biological: graft versus host disease prophylaxis/therapy

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01616056

2617.00 (Other Identifier)

NCI-2012-00862 (Registry Identifier)

P30CA015704 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosis of chronic graft versus host disease (GVHD) as defined by the National Institutes of Health (NIH) criteria
Ocular symptoms of NIH eye score 2 or greater:
- Score 2: Moderate dry eye symptoms partially affecting activities of daily living (ADL) (requiring drops > 3 x per day or punctal plugs), WITHOUT vision impairment
- Score 3: Severe dry eye symptoms significantly affecting ADL (special eyewear to relieve pain) OR unable to work because of ocular symptoms OR loss of vision caused by keratoconjunctivitis
No new systemic immunosuppressive medications within 1 month prior to enrollment
Subject has the ability to understand and willingness to sign a written informed consent document

Exclusion criteria

Absolute neutrophil count < 1000/ul
Known hypersensitivity or allergy to contact lenses
Evidence of any active viral, bacterial, or fungal infection in the eyes that is progressive despite appropriate treatment
Treatment with contact lenses within the previous 3 months for any indication
Active psychiatric disorder, substance abuse or any other reason that would interfere with compliance with the study protocol