New Treatment Application Significantly Reduced Symptomatology in Dry Eye Disease
The use of a sutureless dehydrated amniotic membrane (dAM) administered via a specialized bandage contact lens (sBCL) had a significant, long-term reduction in symptoms for patients with moderate-to-severe dry eye disease (DED).
“This is the first randomized controlled trial, known to the authors, to have a dAM delivered to the ocular surface (by a specialized bandage contact lens applied bilaterally, allowing reasonable vision while having the treatment delivered), compared with the specialized soft bandage contact lens on its own, for the management of moderate-to-severe DED,” the authors wrote of their study.
A total of 93 participants with DED were randomly assigned to receive a 1-week bilateral treatment of dAM applied under a sBCL or a sBCL alone. The sBCL was 17 mm in diameter, with a 6 mm central window.
All participants were assessed at baseline as well as 1 month, 3 months, and 6 months following treatment. The primary outcomes included changes in symptomatology, tear film and ocular surface measurements, and in vivo confocal microscopy imaging of corneal nerve parameters and corneal dendritic cell (CDC) counts.
Patients in the dAM-sBCL group had a 65% reduction in Ocular Surface Disease Index scores at 6 months following treatment (P < .001). Additionally, 88% of this group had improvement at 1-month post-treatment. Significant improvements in corneal nerve parameters were observed at 1 month in the dAM-sBCL group. These positive trends were sustained at 3 months. The dAM-sBCL group also had significant reductions in mature CDC counts, which was suggestive of an anti-inflammatory effect. Both groups had significant reductions in corneal staining.
Limitations of the study include potential for misidentification on in vivo confocal microscopy imaging, low baseline levels of ocular surface staining, and difficulty in monitoring treatment activity due to a lack of evidence on treatment retention and dissolution.
“Treatment with dAM-sBCL for just 1 week significantly and rapidly improved dry eye symptoms as well as ocular surface signs for at least 3 months,” the researchers concluded. “It also enhanced corneal nerve health while reducing activated/mature corneal inflammatory cell numbers, presenting a safe and promising new treatment for moderate-to-severe DED.”
Reference:
Travé-Huarte S, Wolffsohn JS. Sutureless dehydrated amniotic membrane (Omnigen) application using a specialized bandage contact lens (OmniLenz) for the treatment of dry eye disease: a 6-month randomized control trial. Medicina (Kaunas). 2024;60(6):985. doi:10.3390/medicina60060985.