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.


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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.

Reference

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