Study investigates PROSE lenses as drug delivery device for patients with dry eye disease
The study found that the prosthetic replacement of the ocular surface ecosystem lenses were well tolerated in the delivery of non-preserved cyclosporine 0.05%.
Image credit: BostonSight
A recent study found that prosthetic replacement of the ocular surface ecosystem (PROSE) lenses as a drug delivery device for non-preserved cyclosporine 0.05% was well tolerated regarding ocular symptoms and ocular surface signs. The prospective observational pilot study’s purpose was to evaluate the tolerability of the lens in patients with dry eye syndrome, which was measured by evaluating OSDI scores, corneal and conjunctival staining, visual acuity, and conjunctival redness, in addition to administering a tolerability questionnaire.1
Although there was no statistically significant change in best corrected visual acuity when compared with placebo, there was statistically significant improvement without comparing with placebo (p < 0.05) in mean per subject and mean per eye corneal fluorescein staining, conjunctival lissamine staining, and conjunctival hyperemia by slit lamp examination at the 1 month followup.1
“Overall, minimal experience and literature exists regarding this drug delivery system and to our knowledge, this report is the first to ever describe a prospective clinical trial utilizing a pharmaceutical in this manner,” the study authors stated. “More specifically, no study has previously described results of a prospective clinical trial utilizing preservative-free cyclosporine 0.05% ophthalmic emulsion in a PROSE reservoir for the treatment of dry eye disease. The purpose of this pilot study is to provide an initial evaluation of tolerability of such a potential treatment.”
The study involved 14 participants that were enrolled over 14 months and evaluated by the same practitioner at 1 eye care center for the duration of the study. All participants were 18 years of age or older and had already been using or were willing to transition to buffered preservative-free normal saline (PuriLens, The Lifestyle Company) for the PROSE reservoir solution. Participants were also required to have a baseline corneal fluorescein staining of 2 or greater when combing the scores of both eyes.1
Participants instilled 1 drop of cyclosporine in the PROSE reservoir and then filled the reservoir with preservative-free normal saline. After wearing the lens for 6 hours, the reservoir was filled again and worn for another 4 hours. In the 1 month period, OSDI scores decreased by an average of 3.83 ± 6.87 from baseline (p = 0.07). Additionally, both National Eye Institute (NEI) corneal and conjunctival fluorescein staining scores improved (p< 0.05), but there was no statistically significant different responses across the five NEI corneal sections through ANOVA testing. There was also no statistically significant improvement in best corrected visual acuity. Additionally, average conjunctival redness found statistically significant improvement.1
The PROSE lens has been FDA approved as a highly customized scleral lens treatment indicated for management of conditions affects the ocular surface, including keratoconjunctivitis sicca, ocular graft-versus-host disease, neurotrophic keratitis, and Stevens-Johnson syndrome.1
Reference:
- Nakhla MN, Patel R, Crowley E, Li Y, Peiris TB, Brocks D. Utilizing PROSE as a drug delivery device for preservative-free cyclosporine 0.05% for the treatment of dry eye disease: A pilot study. Clin Ophthal. 2024;18:3203-3213. https://doi.org/10.2147/OPTH.S487369
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