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

• Sponsor: Fred Hutchinson Cancer Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01616056
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 20
• Location: 1
• Arm: 1
• Duration (Months): 30
• Patients Per Site Per Month: 0.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Graft Versus Host Disease; Ophthalmologic Complications	Biological: graft versus host disease prophylaxis/therapy; Other: questionnaire administration; Procedure: optical coherence tomography	Phase 2

Detailed Description

PRIMARY OBJECTIVES:

1. To determine the symptom improvement after 2 weeks of therapy with bandage lenses.

SECONDARY OBJECTIVES:

1. To confirm short-term safety within 1 month after bandage lenses.

2. To determine improvement in ophthalmologic examinations after bandage lenses.

3. 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 Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: A Single Center Phase II Study of Bandage Lenses for Ocular Graft-Versus-Host Disease After Allogeneic Hematopoietic Cell Transplantation
• Study Start Date: Jun 1, 2012
• Actual Primary Completion Date: Oct 1, 2014
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

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.	Biological: graft versus host disease prophylaxis/therapy; Wear bandage lenses; Other Names: prophylaxis/therapy, graft versus host disease prophylaxis/therapy, GVHD ; Other: questionnaire administration; Ancillary studies; Procedure: optical coherence tomography; Optional ancillary studies

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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).

3. 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.

4. 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.

5. 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.

6. 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.

Secondary Outcome Measures

1. Number of Patients Who Experienced Serious Adverse Events [1 month]

   Safety of Bandage Contact Lenses at 1 month

2. 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.

3. Change in Optical Coherence Tomography [2 weeks]

   Patients were assessed by ophthalmologists at enrollment, 2 weeks and afterwards as medical needed.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium	Seattle	Washington	United States	98109

Sponsors and Collaborators

• Fred Hutchinson Cancer Center
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Stephanie Lee, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Stephanie Lee, Principal Investigator, Fred Hutchinson Cancer Center
• ClinicalTrials.gov Identifier: NCT01616056
• Other Study ID Numbers: 2617.00; NCI-2012-00862; 2617.00; P30CA015704
• First Posted: Jun 11, 2012
• Last Update Posted: Jul 17, 2017
• Last Verified: Jul 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Stephanie Lee, Principal Investigator, Fred Hutchinson Cancer Center: Chronic graft-versus-host disease; eye
• Additional relevant MeSH terms: Graft vs Host Disease

Study Results

Participant Flow

Arm/Group Title	Bandage Contact Lenses
Arm/Group Description	Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity.
Period Title: Overall Study
STARTED	20
COMPLETED	19
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Bandage Contact Lenses
Arm/Group Description	Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity.
Overall Participants	19
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	55
Sex: Female, Male (Count of Participants)
Female	8 42.1%
Male	11 57.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	17 89.5%
Unknown or Not Reported	2 10.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	1 5.3%
Native Hawaiian or Other Pacific Islander	1 5.3%
Black or African American	0 0%
White	15 78.9%
More than one race	1 5.3%
Unknown or Not Reported	1 5.3%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bandage Contact Lenses
Arm/Group Description	Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity.
Measure Participants	19
Baseline	75.4 (4.25)
2 weeks	63.2 (4.82)
4 weeks	61.8 (4.52)
3 months	56.3 (7.28)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bandage Contact Lenses
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.01
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bandage Contact Lenses
Arm/Group Description	Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity.
Measure Participants	19
2 weeks	9 47.4%
4 weeks	11 57.9%
3 months	9 47.4%

3. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bandage Contact Lenses
Arm/Group Description	Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity.
Measure Participants	19
Baseline	54.5 (6.19)
2 weeks	36.8 (5.32)
4 weeks	32.9 (5.74)
3 months	35.6 (6.50)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bandage Contact Lenses
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.002
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

4. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bandage Contact Lenses
Arm/Group Description	Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity.
Measure Participants	19
2 weeks	10 52.6%
4 weeks	13 68.4%
3 months	10 52.6%

5. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bandage Contact Lenses
Arm/Group Description	Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity.
Measure Participants	19
Baseline	7.11 (0.42)
2 weeks	5.00 (0.56)
4 weeks	4.37 (0.45)
3 months	3.94 (0.59)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bandage Contact Lenses
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

6. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bandage Contact Lenses
Arm/Group Description	Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity.
Measure Participants	19
2 weeks	11 57.9%
4 weeks	13 68.4%
3 months	12 63.2%

7. Secondary Outcome

Title	Number of Patients Who Experienced Serious Adverse Events
Description	Safety of Bandage Contact Lenses at 1 month
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bandage Contact Lenses
Arm/Group Description	Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity.
Measure Participants	19
Count of Participants [Participants]	0 0%

8. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Ophthalmology assessments made after 2 weeks were not analyzed because of incomplete data collection.

Arm/Group Title	Bandage Contact Lenses
Arm/Group Description	Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity.
Measure Participants	19
logMAR visual acuity baseline	0.26 (0.030)
logMAR visual acuity 2 weeks	0.15 (0.030)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bandage Contact Lenses
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.005
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

9. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Optical coherence tomography results were not analyzed because of incomplete data collection.

Arm/Group Title	Bandage Contact Lenses
Arm/Group Description	Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity.
Measure Participants	0

Adverse Events

Time Frame	3 months
Arm/Group Title	Bandage Contact Lenses
Arm/Group Description	Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity.
All Cause Mortality
	Bandage Contact Lenses
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Bandage Contact Lenses
	Affected / at Risk (%)	# Events
Total	0/19 (0%)
Other (Not Including Serious) Adverse Events
	Bandage Contact Lenses
	Affected / at Risk (%)	# Events
Total	14/19 (73.7%)
Eye disorders
Foreign body sensation	14/19 (73.7%)	14
Swollen eye lids	5/19 (26.3%)	5
Excessive tearing	2/19 (10.5%)	2
Corneal edema and stromal haze	1/19 (5.3%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.