Graft Versus Host Disease, Ophthalmologic Complications
Conditions
Keywords
Chronic graft-versus-host disease, eye
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.
Interventions
Wear bandage lenses
OTHERquestionnaire administration
Ancillary studies
PROCEDUREoptical coherence tomography
Optional ancillary studies
Sponsors
National Cancer Institute (NCI)
Fred Hutchinson Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 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. |
| 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 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Change in Optical Coherence Tomography | 2 weeks | Patients were assessed by ophthalmologists at enrollment, 2 weeks and afterwards as medical needed. |
| Number of Patients Who Experienced Serious Adverse Events | 1 month | Safety of Bandage Contact Lenses at 1 month |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bandage Contact Lenses Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity. | 19 |
| Total | 19 |
Baseline characteristics
| Characteristic | Bandage Contact Lenses |
|---|---|
| Age, Continuous | 55 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 15 Participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 14 / 19 |
| serious Total, serious adverse events | 0 / 19 |
Outcome results
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.
Time frame: 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bandage Contact Lenses | Change in Patient-reported Symptoms as Measured by the 11-point Eye Rating Scale | Baseline | 7.11 units on a scale | Standard Deviation 0.42 |
| Bandage Contact Lenses | Change in Patient-reported Symptoms as Measured by the 11-point Eye Rating Scale | 2 weeks | 5.00 units on a scale | Standard Deviation 0.56 |
| Bandage Contact Lenses | Change in Patient-reported Symptoms as Measured by the 11-point Eye Rating Scale | 4 weeks | 4.37 units on a scale | Standard Deviation 0.45 |
| Bandage Contact Lenses | Change in Patient-reported Symptoms as Measured by the 11-point Eye Rating Scale | 3 months | 3.94 units on a scale | Standard Deviation 0.59 |
p-value: 0.001Wilcoxon (Mann-Whitney)
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.
Time frame: 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bandage Contact Lenses | Change in Patient-reported Symptoms as Measured by the Ocular Surface Disease Index | Baseline | 54.5 units on a scale | Standard Deviation 6.19 |
| Bandage Contact Lenses | Change in Patient-reported Symptoms as Measured by the Ocular Surface Disease Index | 2 weeks | 36.8 units on a scale | Standard Deviation 5.32 |
| Bandage Contact Lenses | Change in Patient-reported Symptoms as Measured by the Ocular Surface Disease Index | 4 weeks | 32.9 units on a scale | Standard Deviation 5.74 |
| Bandage Contact Lenses | Change in Patient-reported Symptoms as Measured by the Ocular Surface Disease Index | 3 months | 35.6 units on a scale | Standard Deviation 6.5 |
p-value: 0.002Wilcoxon (Mann-Whitney)
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.
Time frame: 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bandage Contact Lenses | Change in Patient-reported Symptoms Measured by the 8-point Lee Eye Subscale | Baseline | 75.4 units on a scale | Standard Deviation 4.25 |
| Bandage Contact Lenses | Change in Patient-reported Symptoms Measured by the 8-point Lee Eye Subscale | 2 weeks | 63.2 units on a scale | Standard Deviation 4.82 |
| Bandage Contact Lenses | Change in Patient-reported Symptoms Measured by the 8-point Lee Eye Subscale | 4 weeks | 61.8 units on a scale | Standard Deviation 4.52 |
| Bandage Contact Lenses | Change in Patient-reported Symptoms Measured by the 8-point Lee Eye Subscale | 3 months | 56.3 units on a scale | Standard Deviation 7.28 |
p-value: 0.01Wilcoxon (Mann-Whitney)
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.
Time frame: 3 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Bandage Contact Lenses | Number of Participants Who Perceived a Clinically Meaningful Change as Measured by the 11-point Eye Scale | 4 weeks | 13 Participants |
| Bandage Contact Lenses | Number of Participants Who Perceived a Clinically Meaningful Change as Measured by the 11-point Eye Scale | 2 weeks | 11 Participants |
| Bandage Contact Lenses | Number of Participants Who Perceived a Clinically Meaningful Change as Measured by the 11-point Eye Scale | 3 months | 12 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).
Time frame: 3 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Bandage Contact Lenses | Number of Participants Who Perceived a Clinically Meaningful Change as Measured by the 8-level Lee Eye Symptom Subscale | 2 weeks | 9 Participants |
| Bandage Contact Lenses | Number of Participants Who Perceived a Clinically Meaningful Change as Measured by the 8-level Lee Eye Symptom Subscale | 4 weeks | 11 Participants |
| Bandage Contact Lenses | Number of Participants Who Perceived a Clinically Meaningful Change as Measured by the 8-level Lee Eye Symptom Subscale | 3 months | 9 Participants |
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.
Time frame: 3 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Bandage Contact Lenses | Number of Participants Who Perceived a Clinically Meaningful Change as Measured by the OSDI | 2 weeks | 10 Participants |
| Bandage Contact Lenses | Number of Participants Who Perceived a Clinically Meaningful Change as Measured by the OSDI | 4 weeks | 13 Participants |
| Bandage Contact Lenses | Number of Participants Who Perceived a Clinically Meaningful Change as Measured by the OSDI | 3 months | 10 Participants |
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.
Time frame: 2 weeks
Population: Ophthalmology assessments made after 2 weeks were not analyzed because of incomplete data collection.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bandage Contact Lenses | Change in Comprehensive Ophthalmologic Evaluations | logMAR visual acuity baseline | 0.26 logMAR | Standard Deviation 0.03 |
| Bandage Contact Lenses | Change in Comprehensive Ophthalmologic Evaluations | logMAR visual acuity 2 weeks | 0.15 logMAR | Standard Deviation 0.03 |
p-value: 0.005Wilcoxon (Mann-Whitney)
Secondary
Change in Optical Coherence Tomography
Patients were assessed by ophthalmologists at enrollment, 2 weeks and afterwards as medical needed.
Time frame: 2 weeks
Population: Optical coherence tomography results were not analyzed because of incomplete data collection.
Secondary
Number of Patients Who Experienced Serious Adverse Events
Safety of Bandage Contact Lenses at 1 month
Time frame: 1 month
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bandage Contact Lenses | Number of Patients Who Experienced Serious Adverse Events | 0 Participants |