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

Overview

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.

Full Title of Study: “A Single Center Phase II Study of Bandage Lenses for Ocular Graft-Versus-Host Disease After Allogeneic Hematopoietic Cell Transplantation”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2014

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

  • Biological: graft versus host disease prophylaxis/therapy
    • Wear bandage lenses
  • Other: questionnaire administration
    • Ancillary studies
  • Procedure: optical coherence tomography
    • Optional ancillary studies

Arms, Groups and Cohorts

  • Experimental: Bandage Contact Lenses
    • Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity.

Clinical Trial Outcome Measures

Primary 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 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 99 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fred Hutchinson Cancer Research Center
  • Collaborator
    • National Cancer Institute (NCI)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Stephanie Lee, Principal Investigator – Fred Hutchinson Cancer Research Center
  • Overall Official(s)
    • Stephanie Lee, Principal Investigator, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Citations Reporting on Results

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.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.