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

NCT01616056 | Completed Phase 2 Results

• 3 other identifiers: 2617.00NCI-2012-00862P30CA015704
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Graft Versus Host Disease; Ophthalmologic Complications

Keywords

Chronic graft-versus-host disease; eye

Outcome Measures

Primary Outcomes (6)

• 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.

  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).

  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.

  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.

  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.

  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.

  3 months

Secondary Outcomes (3)

• Number of Patients Who Experienced Serious Adverse Events

  1 month

• Change in Comprehensive Ophthalmologic Evaluations

  2 weeks

• Change in Optical Coherence Tomography

  2 weeks

Study Arms (1)

Bandage Contact Lenses

EXPERIMENTAL

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; Other: questionnaire administration; Procedure: optical coherence tomography

Interventions

graft versus host disease prophylaxis/therapy BIOLOGICAL

Wear bandage lenses

Also known as: prophylaxis/therapy, graft versus host disease, prophylaxis/therapy, GVHD

Bandage Contact Lenses

questionnaire administration OTHER

Ancillary studies

Bandage Contact Lenses

optical coherence tomography PROCEDURE

Optional ancillary studies

Bandage Contact Lenses

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

Related Publications (1)

• 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.

  PMID: 26189353 RESULT

MeSH Terms

Conditions

Graft vs Host Disease; Bronchiolitis Obliterans Syndrome

Interventions

Therapeutics; Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Immune System Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Results Point of Contact

• Title: Stephanie J. Lee MD MPH
• Organization: FHCRC

sjlee@fhcrc.org

206-667-6190

Study Officials

• Stephanie Lee

  Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 6, 2012
• First Posted: June 11, 2012
• Study Start: June 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: December 1, 2014
• Last Updated: July 17, 2017
• Results First Posted: July 17, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)