PROSE well-tolerated as delivery device for preservative-free cyclosporine in dry eye
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Key takeaways:
- Researchers reported improvements at 1 month in OSDI scores, corneal fluorescein staining, and conjunctival staining and redness.
- Tolerability scores were similar before and after treatment.
The Prosthetic Replacement of Ocular Surface Ecosystem was well-tolerated and appeared efficacious as a delivery system for preservative-free cyclosporine 0.05% in the treatment of dry eye disease, according to results of a pilot study.
“The ophthalmic and optometric community is in the infancy of investigating the potential use of PROSE or scleral lenses as a drug delivery system for preservative-free ocular topical medications,” Monica Nabil Nakhla, from Tufts University School of Medicine, and colleagues wrote in Clinical Ophthalmology.
To evaluate the tolerability of the Prosthetic Replacement of Ocular Surface Ecosystem (PROSE, BostonSight) as a means of delivering preservative-free cyclosporine 0.05%, Nakhla and colleagues conducted a prospective, observational pilot study of 14 adult patients with dry eye disease, all of whom were current PROSE wearers.
Participants instilled one drop of Restasis (cyclosporine ophthalmic emulsion 0.05%, AbbVie) in the PROSE reservoir, filling the remainder with PuriLens (preservative-free normal saline, The Lifestyle Co.) and wore the device for 6 hours. They then removed the PROSE and repeated the protocol for at least another 4 hours.
For the nine patients (18 eyes; mean age, 54.33 years) who completed the study, Ocular Surface Disease Index scores at 1 month decreased by an average of 3.83 from baseline, with a maximum improvement of 16.67. Participants also demonstrated significant improvement in corneal fluorescein staining, conjunctival staining and conjunctival redness at both 1 week and 1 month.
The researchers reported no significant improvement or worsening in best corrected visual acuity.
Tolerability scores were statistically equivalent before and after treatment at 1 week and 1 month, with participants reporting on average that the protocol was easy to perform.
“Overall, the data analyzed in this report support further investigation into the safety and efficacy of utilizing the PROSE reservoir as a cyclosporine 0.05% drug delivery system for the treatment of dry eye,” the researchers wrote. “Additionally, this report underscores the importance of a standardized scientific stepwise approach to the utilization of PROSE or scleral lenses as a drug delivery system.”
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