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Abstract
Purpose
To report the subjective assessment of topical self-administered, cadaver-derived corneal epithelial stem cell supernatant for treatment of severe dry eye disease (DED).
Methods
Thirty-four eyes of 17 patients with advanced DED as defined by Standardized Patient Evaluation of Eye Dryness (SPEEDTM) questionnaire ≥14, Ocular Surface Disease Index (OSDI©) score ≥40 and documented attempt of at least six conventional dry eye therapies were enrolled into a prospective clinical trial at a single private practice institution. Treatment consisted of patient self-administered topical instillation of the corneal epithelial stem cell-derived product four times daily in both eyes for 12 weeks. Patient-reported outcome measures (PROMs) were taken with the SPEEDTM questionnaire (the main outcome variable), OSDI© score and visual analog score (VAS; UNC Dry Eye Management Scale©), and objective clinical measurements were taken with best-corrected visual acuity (BCVA), corneal topographic index measurements and tear film osmolarity. These measurements were compared at baseline versus the endpoint at completion of the 12-week treatment.
Results
All 34 eyes tolerated the treatment without any adverse events or significant side effects. Compared with baseline, both the SPEEDTM questionnaire and the VAS significantly improved at the conclusion of the 12-week treatment (p = 0.0054 and p = 0.0202, respectively). The OSDI© improved by an average of 10.9 points after the treatment but was not statistically significant (p = 0.1409). There were no significant changes in any of the objective clinical measurements. None of the study subjects failed to complete the treatment course, experienced decrease in any of the PROMs or lost one or more lines of BCVA during the follow-up period.
Conclusion
Topical corneal epithelial stem cell-derived supernatant that can be self-administered by the patient shows promise at improving patient symptoms and quality of life in the setting of severe DED that is unresponsive to conventional therapies.
Abbreviations
DED, dry eye disease; BCVA, best corrected visual acuity; LogMAR, logarithm of minimum angle of resolution; PROMs, patient reported outcome measures; SPEEDTM, Standardized Patient Evaluation of Eye Dryness; OSDI©, Ocular Surface Disease Index; VAS, visual analog score; HCT/Ps, Human Cells, Tissues, and Cellular and Tissue-Based Products; cGMP, Current Good Manufacturing Practice.
Declarations
The study was approved by the Salus Independent Review Board in accordance with the Ethical Standards laid down in the Declaration of Helsinki.
The datasets used and/or analyzed during the current study are available from the corresponding authors on reasonable requests.
Author Contributions
All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.
Disclosure
SWR and HD have proprietary interest in the biologic treatment studied. SWR and HD are managing partners of RegenKera, LLC which has an exclusive licensing agreement with Texas Tech University System for the patent-pending technology used to create the biologic product. SWR has a patent Stem cell supernatant manufacturing techniques pending to RegenKera, LLC. HD reports a patent WO 2020/018868 A1 pending. JC is affiliated with Oklahoma Blood Institute which has played a role in manufacturing the product used in this clinical trial. None of the investigators were paid to participate in the execution of the clinical study.