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

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.

Study Overview

• Status: Completed
• Conditions: Graft Versus Host Disease; Ophthalmologic Complications
• Intervention / Treatment: Other: questionnaire administration; Biological: graft versus host disease prophylaxis/therapy; Procedure: optical coherence tomography

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98109
      • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fred Hutchinson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Stephanie Lee, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Publications and helpful links

General Publications

• Inamoto Y, Sun YC, Flowers ME, Carpenter PA, Martin PJ, Li P, Wang R, Chai X, Storer BE, Shen TT, Lee SJ. Bandage Soft Contact Lenses for Ocular Graft-versus-Host Disease. Biol Blood Marrow Transplant. 2015 Nov;21(11):2002-7. doi: 10.1016/j.bbmt.2015.07.013. Epub 2015 Jul 17.

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: June 6, 2012
• First Submitted That Met QC Criteria: June 7, 2012
• First Posted (Estimate): June 11, 2012

Study Record Updates

• Last Update Posted (Actual): July 17, 2017
• Last Update Submitted That Met QC Criteria: July 14, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: eye; Chronic graft-versus-host disease
• Additional Relevant MeSH Terms: Immune System Diseases; Graft vs Host Disease
• Other Study ID Numbers: 2617.00 (Other Identifier: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium); P30CA015704 (U.S. NIH Grant/Contract); NCI-2012-00862 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All data are available now for sharing. Researchers must contact Stephanie Lee and sign a data use agreement.