Clinical trial NCT01616056: Bandage Lenses in Treating Patients With Ocular Graft-Versus-Host Disease
Official title: A Single Center Phase II Study of Bandage Lenses for Ocular Graft-Versus-Host Disease After Allogeneic Hematopoietic Cell Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Graft Versus Host Disease
Ophthalmologic Complications
Keywords: Chronic graft-versus-host disease
eye
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-06-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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 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

Primary outcomes:
measure: Change in Patient-reported Symptoms Measured by the 8-point Lee Eye Subscale
timeFrame: 3 months
measure: Number of Participants Who Perceived a Clinically Meaningful Change as Measured by the 8-level Lee Eye Symptom Subscale
timeFrame: 3 months
measure: Change in Patient-reported Symptoms as Measured by the Ocular Surface Disease Index
timeFrame: 3 months
measure: Number of Participants Who Perceived a Clinically Meaningful Change as Measured by the OSDI
timeFrame: 3 months
measure: Change in Patient-reported Symptoms as Measured by the 11-point Eye Rating Scale
timeFrame: 3 months
measure: Number of Participants Who Perceived a Clinically Meaningful Change as Measured by the 11-point Eye Scale
timeFrame: 3 months
Secondary outcomes:
measure: Number of Patients Who Experienced Serious Adverse Events
timeFrame: 1 month
measure: Change in Comprehensive Ophthalmologic Evaluations
timeFrame: 2 weeks
measure: Change in Optical Coherence Tomography
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
name: Stephanie Lee
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.