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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-00862 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2617.00 | Other Identifier | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | |
| P30CA015704 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bandage Contact Lenses | Experimental | Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| graft versus host disease prophylaxis/therapy | Biological | Wear bandage lenses |
|
| 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. |
| 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. |
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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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Stephanie Lee | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26189353 | Result | 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. |
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All data are available now for sharing. Researchers must contact Stephanie Lee and sign a data use agreement.
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| ID | Title | Description |
|---|---|---|
| FG000 | Bandage Contact Lenses | Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bandage Contact Lenses | Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | 3 months |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bandage Contact Lenses | Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Foreign body sensation | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephanie J. Lee MD MPH | FHCRC | 206-667-6190 | sjlee@fhcrc.org |
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| ID | Term |
|---|---|
| D006086 | Graft vs Host Disease |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D041623 | Tomography, Optical Coherence |
| ID | Term |
|---|---|
| D041622 | Tomography, Optical |
| D061848 | Optical Imaging |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
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| questionnaire administration | Other | Ancillary studies |
|
| optical coherence tomography | Procedure | Optional ancillary studies |
|
| 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 |
| 2 weeks |
| Change in Optical Coherence Tomography | Patients were assessed by ophthalmologists at enrollment, 2 weeks and afterwards as medical needed. | 2 weeks |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Primary | 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). | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | 3 months |
|
|
|
|
| Primary | 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. | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | 3 months |
|
|
|
|
| Primary | 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. | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Secondary | Number of Patients Who Experienced Serious Adverse Events | Safety of Bandage Contact Lenses at 1 month | Posted | Count of Participants | Participants | 1 month |
|
|
|
| Secondary | 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. | Ophthalmology assessments made after 2 weeks were not analyzed because of incomplete data collection. | Posted | Mean | Standard Deviation | logMAR | 2 weeks |
|
|
|
|
| Secondary | Change in Optical Coherence Tomography | Patients were assessed by ophthalmologists at enrollment, 2 weeks and afterwards as medical needed. | Optical coherence tomography results were not analyzed because of incomplete data collection. | Posted | 2 weeks |
|
|
| 0 |
| 19 |
| 14 |
| 19 |
| Swollen eye lids | Eye disorders | Systematic Assessment |
|
| Excessive tearing | Eye disorders | Systematic Assessment |
|
| Corneal edema and stromal haze | Eye disorders | Systematic Assessment |
|
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| D001991 |
| Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D003933 | Diagnosis |
| D014054 | Tomography |
| D008919 | Investigative Techniques |
| Title |
|---|
| Measurements |
|---|
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| Title | Measurements |
|---|---|
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| 3 months |
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| Title | Measurements |
|---|
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| Title |
|---|
| Measurements |
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| 3 months |
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