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

Graft Versus Host Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01616056
• Other study ID #: 2617.00
• Secondary ID: NCI-2012-0086226
• Status: Completed
• Phase: Phase 2
• First received: June 6, 2012
• Last updated: July 14, 2017
• Start date: June 2012
• Est. completion date: December 2014

Study information

• Verified date: July 2017
• Source: Fred Hutchinson Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Graft Versus Host Disease
• Graft vs Host Disease
• Ophthalmologic Complications

Intervention

Biological:
• graft versus host disease prophylaxis/therapy
Wear bandage lenses

Other:
• questionnaire administration
Ancillary studies

Procedure:
• optical coherence tomography
Optional ancillary studies

Locations

Country	Name	City	State
United States	Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Research Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & 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.2015.07.0 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Number of Patients Who Experienced Serious Adverse Events	Safety of Bandage Contact Lenses at 1 month	1 month
Secondary	Change in Comprehensive Ophthalmologic Evaluations	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.	2 weeks
Secondary	Change in Optical Coherence Tomography	Patients were assessed by ophthalmologists at enrollment, 2 weeks and afterwards as medical needed.	2 weeks