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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Stephanie Lee, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT01616056
First received: June 6, 2012
Last updated: July 14, 2017
Last verified: July 2017
  Purpose
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 Intervention Phase
Graft Versus Host Disease Ophthalmologic Complications Biological: graft versus host disease prophylaxis/therapy Other: questionnaire administration Procedure: optical coherence tomography Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
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

Resource links provided by NLM:


Further study details as provided by Stephanie Lee, Fred Hutchinson Cancer Research Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Number of Patients Who Experienced Serious Adverse Events [ Time Frame: 1 month ]
    Safety of Bandage Contact Lenses at 1 month

  • Change in Comprehensive Ophthalmologic Evaluations [ Time Frame: 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 [ Time Frame: 2 weeks ]
    Patients were assessed by ophthalmologists at enrollment, 2 weeks and afterwards as medical needed.


Enrollment: 20
Study Start Date: June 2012
Study Completion Date: December 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01616056

Locations
United States, Washington
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Stephanie Lee Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
  More Information

Publications:
Responsible Party: Stephanie Lee, Principal Investigator, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT01616056     History of Changes
Other Study ID Numbers: 2617.00
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 )
Study First Received: June 6, 2012
Results First Received: January 13, 2017
Last Updated: July 14, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All data are available now for sharing. Researchers must contact Stephanie Lee and sign a data use agreement.

Keywords provided by Stephanie Lee, Fred Hutchinson Cancer Research Center:
Chronic graft-versus-host disease
eye

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases

ClinicalTrials.gov processed this record on July 26, 2017