Phase 2 N=20 Supportive Care

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

Graft Versus Host Disease · Ophthalmologic Complications

Bottom Line

View on ClinicalTrials.gov: NCT01616056 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2017

Primary outcome: Primary: Change in Patient-reported Symptoms Measured by the 8-point Lee Eye Subscale — 75.4; 63.2; 61.8; 56.3 units on a scale — p=0.01

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: graft versus host disease prophylaxis/therapy (Biological); questionnaire administration (Other); optical coherence tomography (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Fred Hutchinson Cancer Center
Primary completion: Oct 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Patient-reported Symptoms Measured by the 8-point Lee Eye Subscale	75.4; 63.2; 61.8; 56.3	0.01 sig
PRIMARY Number of Participants Who Perceived a Clinically Meaningful Change as Measured by the 8-level Lee Eye Symptom Subscale	9; 11; 9	—
PRIMARY Change in Patient-reported Symptoms as Measured by the Ocular Surface Disease Index	54.5; 36.8; 32.9; 35.6	0.002 sig
PRIMARY Number of Participants Who Perceived a Clinically Meaningful Change as Measured by the OSDI	10; 13; 10	—
PRIMARY Change in Patient-reported Symptoms as Measured by the 11-point Eye Rating Scale	7.11; 5.00; 4.37; 3.94	0.001 sig
PRIMARY Number of Participants Who Perceived a Clinically Meaningful Change as Measured by the 11-point Eye Scale	11; 13; 12	—
SECONDARY Number of Patients Who Experienced Serious Adverse Events	—	—
SECONDARY Change in Comprehensive Ophthalmologic Evaluations	0.26; 0.15	0.005 sig
SECONDARY Change in Optical Coherence Tomography	—	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01616056). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.