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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2014-12-31

Brief Summary

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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.

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Detailed Description

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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

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Graft Versus Host Disease Ophthalmologic Complications

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Bandage Contact Lenses

Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity.

Group Type EXPERIMENTAL

graft versus host disease prophylaxis/therapy

Intervention Type BIOLOGICAL

Wear bandage lenses

questionnaire administration

Intervention Type OTHER

Ancillary studies

optical coherence tomography

Intervention Type PROCEDURE

Optional ancillary studies

Interventions

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graft versus host disease prophylaxis/therapy

Wear bandage lenses

Intervention Type BIOLOGICAL

questionnaire administration

Ancillary studies

Intervention Type OTHER

optical coherence tomography

Optional ancillary studies

Intervention Type PROCEDURE

Other Intervention Names

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prophylaxis/therapy, graft versus host disease prophylaxis/therapy, GVHD

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No