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

Study Overview
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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.

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.

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

Conditions
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Graft Versus Host Disease, Ophthalmologic Complications

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


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bandage Contact Lenses<br>Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity. | Biological: graft versus host disease prophylaxis/therapy<br>* Wear bandage lenses<br>* Other names: prophylaxis/therapy, GVHD;Other: questionnaire administration<br>* Ancillary studies<br>Procedure: optical coherence tomography<br>* Optional ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Patient-reported Symptoms Measured by the 8-point Lee Eye Subscale | 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. | 3 months | 
| Number of Participants Who Perceived a Clinically Meaningful Change as Measured by the 8-level Lee Eye Symptom Subscale | 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). | 3 months | 
| Change in Patient-reported Symptoms as Measured by the Ocular Surface Disease Index | 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. | 3 months | 
| Number of Participants Who Perceived a Clinically Meaningful Change as Measured by the OSDI | 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. | 3 months | 
| Change in Patient-reported Symptoms as Measured by the 11-point Eye Rating Scale | 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. | 3 months | 
| Number of Participants Who Perceived a Clinically Meaningful Change as Measured by the 11-point Eye Scale | 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. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients Who Experienced Serious Adverse Events | Safety of Bandage Contact Lenses at 1 month | 1 month | 
| Change in Comprehensive Ophthalmologic Evaluations | 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. | 2 weeks | 
| Change in Optical Coherence Tomography | Patients were assessed by ophthalmologists at enrollment, 2 weeks and afterwards as medical needed. | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic graft-versus-host disease, eye