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NCT Number: NCT01616056

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

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.

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Key information

Conditions

Graft Versus Host Disease Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Graft vs Host Disease Immune System Diseases Lung Diseases Lung Diseases, Obstructive Ophthalmologic Complications Organizing Pneumonia Respiratory Tract Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

graft versus host disease prophylaxis/therapy

Biological

Wear bandage lenses

Other names: prophylaxis/therapy, graft versus host disease, prophylaxis/therapy, GVHD

Questionnaire Administration

Other

Ancillary studies

Optical Coherence Tomography

Procedure

Optional ancillary studies

Primary outcomes

  1. 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.

  2. 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).

  3. 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.

  4. 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.

  5. 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.

  6. 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 outcomes

  1. Number of Patients Who Experienced Serious Adverse Events

    Time frame: 1 month

    Safety of Bandage Contact Lenses at 1 month

  2. 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.

  3. Change in Optical Coherence Tomography

    Time frame: 2 weeks

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

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jun 11, 2012
Registry last updated
Jul 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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