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

Phase 2

Completed

Conditions: Graft Versus Host Disease
Ophthalmologic Complications

Interventions: Biological: graft versus host disease prophylaxis/therapy
Other: questionnaire administration
Procedure: optical coherence tomography

Registration Number: NCT01616056

Lead Sponsor: Fred Hutchinson Cancer Center

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 20

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bandage Contact Lenses	questionnaire administration	Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity.
Bandage Contact Lenses	graft versus host disease prophylaxis/therapy	Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity.
Bandage Contact Lenses	optical coherence tomography	Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measures

Name	Time	Method
Change in Patient-reported Symptoms as Measured by the 11-point Eye Rating Scale	3 months	The 11-point eye scale goes from 0 not present to 10 as bad as you can imagine. Clinically meaningful change is defined as a 2 point or more decrease.
Change in Patient-reported Symptoms Measured by the 8-point Lee Eye Subscale	3 months	Lee eye subscale: sx6 dry eyes, sx7 need to use eye drops frequently, sx8 difficulty seeing clearly 0=not at all, 4=extremely bothered. If have at least one of (sx6,sx7,sx8), then sx_eye=mean(sx6,sx7,sx8)\*25. Minimum possible score: 0 correlated with better outcome, maximum score possible: 100 correlated with worse outcome. Clinically meaningful change is half a standard deviation, which is a decrease of 11.8 of more for this scale.
Number of Participants Who Perceived a Clinically Meaningful Change as Measured by the OSDI	3 months	OSDI minimum score: 0, correlated with better outcome, maximum score: 100, correlated with worse outcome. 12 questions 0 none of the time to 4 all of the time. (Sum of scores)x25/number of questions answered. Clinically meaningful change scores are half a standard deviation, which is 10.9 for the OSDI.
Number of Participants Who Perceived a Clinically Meaningful Change as Measured by the 8-level Lee Eye Symptom Subscale	3 months	8-level change score is from 0 completely gone to 7 very much worse. Clinically meaningful improvement is defined as half a standard deviation (decreased score of 11.8 or greater).
Change in Patient-reported Symptoms as Measured by the Ocular Surface Disease Index	3 months	OSDI minimum score: 0, correlated with better outcome, maximum score: 100, correlated with worse outcome. 12 questions 0 none of the time to 4 all of the time. (Sum of scores)x25/number of questions answered. Clinically meaningful change scores are half a standard deviation, which is 10.9 for the OSDI.
Number of Participants Who Perceived a Clinically Meaningful Change as Measured by the 11-point Eye Scale	3 months	The 11-point eye scale goes from 0 not present to 10 as bad as you can imagine. Clinically meaningful change is defined as a 2 point or more decrease.

Secondary Outcome Measures

Name	Time	Method
Number of Patients Who Experienced Serious Adverse Events	1 month	Safety of Bandage Contact Lenses at 1 month
Change in Optical Coherence Tomography	2 weeks	Patients were assessed by ophthalmologists at enrollment, 2 weeks and afterwards as medical needed.
Change in Comprehensive Ophthalmologic Evaluations	2 weeks	LogMAR visual acuity score of 0 is equivalent to 20/20 vision. Patients were assessed by ophthalmologists at enrollment, 2 weeks and afterwards as medical needed.