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

Primary Purpose

Graft Versus Host Disease, Ophthalmologic Complications

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
graft versus host disease prophylaxis/therapy
questionnaire administration
optical coherence tomography
Sponsored by
Fred Hutchinson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Graft Versus Host Disease focused on measuring Chronic graft-versus-host disease, eye

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bandage Contact Lenses

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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).
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.
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.
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.
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.

Secondary Outcome Measures

Number of Patients Who Experienced Serious Adverse Events
Safety of Bandage Contact Lenses at 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.
Change in Optical Coherence Tomography
Patients were assessed by ophthalmologists at enrollment, 2 weeks and afterwards as medical needed.

Full Information

First Posted
June 6, 2012
Last Updated
July 14, 2017
Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01616056
Brief Title
Bandage Lenses in Treating Patients With Ocular Graft-Versus-Host Disease
Official Title
A Single Center Phase II Study of Bandage Lenses for Ocular Graft-Versus-Host Disease After Allogeneic Hematopoietic Cell Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Graft Versus Host Disease, Ophthalmologic Complications
Keywords
Chronic graft-versus-host disease, eye

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bandage Contact Lenses
Arm Type
Experimental
Arm Description
Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity.
Intervention Type
Biological
Intervention Name(s)
graft versus host disease prophylaxis/therapy
Other Intervention Name(s)
prophylaxis/therapy, graft versus host disease, prophylaxis/therapy, GVHD
Intervention Description
Wear bandage lenses
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Intervention Description
Ancillary studies
Intervention Type
Procedure
Intervention Name(s)
optical coherence tomography
Intervention Description
Optional ancillary studies
Primary Outcome Measure Information:
Title
Change in Patient-reported Symptoms Measured by the 8-point Lee Eye Subscale
Description
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.
Time Frame
3 months
Title
Number of Participants Who Perceived a Clinically Meaningful Change as Measured by the 8-level Lee Eye Symptom Subscale
Description
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).
Time Frame
3 months
Title
Change in Patient-reported Symptoms as Measured by the Ocular Surface Disease Index
Description
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.
Time Frame
3 months
Title
Number of Participants Who Perceived a Clinically Meaningful Change as Measured by the OSDI
Description
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.
Time Frame
3 months
Title
Change in Patient-reported Symptoms as Measured by the 11-point Eye Rating Scale
Description
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.
Time Frame
3 months
Title
Number of Participants Who Perceived a Clinically Meaningful Change as Measured by the 11-point Eye Scale
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Number of Patients Who Experienced Serious Adverse Events
Description
Safety of Bandage Contact Lenses at 1 month
Time Frame
1 month
Title
Change in Comprehensive Ophthalmologic Evaluations
Description
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.
Time Frame
2 weeks
Title
Change in Optical Coherence Tomography
Description
Patients were assessed by ophthalmologists at enrollment, 2 weeks and afterwards as medical needed.
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie Lee
Organizational Affiliation
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All data are available now for sharing. Researchers must contact Stephanie Lee and sign a data use agreement.
Citations:
PubMed Identifier
26189353
Citation
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.
Results Reference
result

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

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