A topical treatment for dry eye disease (DED) demonstrated therapeutic effects, subjective patient reporting shows in a report published in Clinical Ophthalmology. Patients’ visual analog score (VAS) and patient-reported outcome measures (PROMs) significantly improved in the first human clinical trial of a topical corneal epithelial cell-derived DED treatment.
The prospective pilot case series (ClinicalTrials.gov: NCT03302273) drew patients with DED from a single private practice in Texas. The patients (ages 25-75 years) had previously attempted at least 6 conventional dry eye therapies and had an Ocular Surface Disease Index (OSDI) score of at least 40. The 17 patients (all female, 16 White, mean age 57.9 years) self-administered a corneal epithelial stem cell-derived eye drop product 4 times daily to both eyes for 12 weeks.
The patients who participated had previously attempted a mean of 9.1 (±2.6) treatments. All patients had used artificial treatments, lubricating ophthalmic ointments, and topical cyclosporine.
No patients reported worsening in any PROMs. Scores on the Standardized Patient Evaluation of Eye Dryness (SPEED) questionnaire improved throughout the course of the study by a mean of 4.7 points (23%, P =.0054). By the completion of the study, VAS had improved from baseline by a mean of 1.1 points (14.1%, P =.0202). OSDI score, best-corrected visual acuity (BCVA), and tear film osmolarity improved but were not statistically significant, investigators report. No patient lost 1 or more lines of BCVA in the follow-up period.
In exit surveys, all patients reported the treatment was better than artificial tears and reported decreased use of artificial tears during the 12 weeks.
Investigators report some deleterious responses, including 2 patients who reported transient stinging or burning, 2 who reported a mild aftertaste, 1 who noticed itching, and 1 who noticed mattering or crusting that correlated with instillation of the drops. Subconjunctival hemorrhage was reported in 1 patient.
Limitations of the study included the lack of a control group and the brief follow-up period.
Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Rush SW, Chain J, Das H. Corneal epithelial stem cell supernatant in the treatment of severe dry eye disease: a pilot study. Clin Ophthalmol. 2021;15:3097-3107. doi:10.2147/OPTH.S322079