Graft Versus Host DiseasePhase 2NCT01616056
Bandage Lenses in Treating Patients With Ocular Graft-Versus-Host Disease
A Phase 2 study testing graft versus host disease prophylaxis/therapy, questionnaire administration and optical coherence tomography in people with Graft Versus Host Disease and Ophthalmologic Complications, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Graft Versus Host Disease, Ophthalmologic Complications
- What is being tested?
- graft versus host disease prophylaxis/therapy, questionnaire administration and optical coherence tomography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Dec 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the symptom improvement after 2 weeks of therapy with bandage lenses.
SECONDARY OBJECTIVES:
- 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.
- Being tested
- graft versus host disease prophylaxis/therapy, questionnaire administration, optical coherence tomography
- Keywords
- Chronic graft-versus-host disease, eye
- Medical subject headings
- Graft vs Host Disease, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
graft versus host disease prophylaxis/therapyBiological
Also called prophylaxis/therapy, graft versus host disease, prophylaxis/therapy, GVHD
Wear bandage lenses
questionnaire administrationOther
Ancillary studies
optical coherence tomographyProcedure or surgery
Optional ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Bandage Contact Lenses | Experimental | Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity. Receives: Biological: graft versus host disease prophylaxis/therapy; Other: questionnaire administration; Procedure: optical coherence tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months
Secondary outcomes (3)
Number of Patients Who Experienced Serious Adverse Events
Safety of Bandage Contact Lenses at 1 month
Measured: 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.
Measured: 2 weeks
Change in Optical Coherence Tomography
Patients were assessed by ophthalmologists at enrollment, 2 weeks and afterwards as medical needed.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionOct 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Graft Versus Host DiseaseStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Stephanie Lee, Fred Hutchinson Cancer Center
- Investigators
- Stephanie Lee, Principal investigator, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01616056
- Sponsor's protocol ID
- 2617.00
- Other IDs
- NCI-2012-00862, 2617.00, P30CA015704
- Status last verified
- Jul 2017
- First submitted
- 6 Jun 2012
- Last updated
- 17 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: All data are available now for sharing. Researchers must contact Stephanie Lee and sign a data use agreement.
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.
PubMed 26189353
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center Phase II Study of Bandage Lenses for Ocular Graft-Versus-Host Disease After Allogeneic Hematopoietic Cell Transplantation
- ClinicalTrials.gov ID
- NCT01616056
- Acronym / sponsor ID
- 2617.00
- Keywords
- Chronic graft-versus-host disease, eye
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 11 Jun 2012 (estimated)
- Results
- Posted 17 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To determine the symptom improvement after 2 weeks of therapy with bandage lenses.
SECONDARY OBJECTIVES:
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bandage Contact Lenses | Experimental | Biological: graft versus host disease prophylaxis/therapy, Other: questionnaire administration, Procedure: optical coherence tomographyPatients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| graft versus host disease prophylaxis/therapyAlso: prophylaxis/therapy, graft versus host disease, prophylaxis/therapy, GVHDWear bandage lenses | Biological | Bandage Contact Lenses |
| questionnaire administrationAncillary studies | Other | Bandage Contact Lenses |
| optical coherence tomographyOptional ancillary studies | Procedure or surgery | Bandage Contact Lenses |
Primary outcome
Change in Patient-reported Symptoms Measured by the 8-point Lee Eye Subscale
Time frame: 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
Time frame: 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).
Change in Patient-reported Symptoms as Measured by the Ocular Surface Disease Index
Time frame: 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
Time frame: 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
Time frame: 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.
Number of Participants Who Perceived a Clinically Meaningful Change as Measured by the 11-point Eye Scale
Time frame: 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.
3 secondary outcomes
Number of Patients Who Experienced Serious Adverse Events
Time frame: 1 month
Change in Comprehensive Ophthalmologic Evaluations
Time frame: 2 weeks
Change in Optical Coherence Tomography
Time frame: 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26189353Inamoto 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.
- Individual participant dataSharing planned: Yes. All data are available now for sharing. Researchers must contact Stephanie Lee and sign a data use agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie Lee principal investigator
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing graft versus host disease prophylaxis/therapy, questionnaire administration and optical coherence tomography in people with Graft Versus Host Disease and Ophthalmologic Complications, run by Fred Hutchinson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Patient-reported Symptoms Measured by the 8-point Lee Eye Subscale (time frame: 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01616056, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2017.