A Phase II Study of Bandage Contact Lenses for Ocular Graft-Versus-Host Disease

Background: Ocular involvement occurs in more than half of patients with chronic graft-versus-host disease (GVHD), compromising both quality of life and function. Ocular GVHD can be refractory to treatment once dry eye syndrome is established. A bandage contact lens (BCL) is a widely available, disposable, soft contact lens used for the treatment of a diseased or injured cornea. We performed a phase II trial of BCLs for patients with ocular GVHD.

Methods: Eligibility criteria included adult patients with moderate to severe ocular GVHD according to NIH consensus criteria. BCLs were replaced every 2-4 weeks. Patients were instructed to use daily antibiotic eye drops to prevent ocular infection. Patients completed standardized symptom questionnaires at enrollment and at 2 weeks, 4 weeks and 3 months after placement of BCLs. The primary endpoint was symptom improvement by the Lee eye subscale after 2 weeks of therapy. Secondary endpoints included improvement in ocular surface disease index (OSDI), 11-point eye symptom rating and ophthalmologic assessments during 3 months of therapy. For patient-reported measures, higher scores indicate worse symptoms. Measures at follow-up assessments were compared with those at enrollment by paired t-test. Patients gave written consent to participate in the study and the Institutional Review Board approved the study.

Results: Nineteen patients participated in the study from August 2012 to August 2014. Median age was 55 years (range, 32-75), and median time from transplantation to enrollment was 36.5 months (range, 8-157 months). Fourteen patients had moderate ocular GVHD and 5 had severe ocular GVHD at enrollment. The mean Lee eye subscale score at enrollment was 75, and the score improved significantly at 2 weeks (mean 63; p=0.02) and thereafter (Figure). The mean OSDI score at enrollment was 55.5, and the score improved significantly at 2 weeks (mean 37.1; p=0.002) and thereafter. According to the Lee eye subscale, 44% showed clinically meaningful improvement at 2 weeks, 53% at 4 weeks and 54% at 3 months. According to ophthalmologic examination at 2 weeks, ocular GVHD showed 89% improvement, 5% stability and 5% worsening. At 2 weeks, one patient stopped BCLs due to discomfort, and another patient did not wear one lens after it fell out. At 3 months, 2 patients stopped using BCLs after eye symptoms had sufficiently improved, and another patient stopped using BCL due to blurred vision. The most frequent adverse events within 3 months after BCL placement included foreign body sensation (74%), swollen eyelids (26%) and excessive tearing (11%). No ocular infection or other corneal complications were documented during the 3 months.

Conclusion: BCLs are a safe, tolerable and effective treatment that improves symptoms of moderate to severe ocular GVHD in approximately 50% of patients. This study was registered at www.clinicaltrials.gov as NCT01616056.