Corneal Epithelial Stem Cell Supernatant in the Treatment of Severe Dry Eye Disease: A Pilot Study

Figures & data

Table 1 Corneal Epithelial Stem Cell-Derived Supernatant for Dry Eye Disease. Baseline Demographics and Characteristics of the Study Population

Baseline Characteristics and Demographics (n=34 Eyes of 17 Patients)	Means with (Standard Deviations)
Age (years)	57.9 (±13.7)
	Range = 27 to 75
Gender	Male = 0 (0.0%)
	Female = 17 (100.0%)
Ethnicity	Caucasian = 16 (94.1%)
	Hispanic = 1 (5.9%)
	Other = 0 (0.0%)
Number of Previous Dry Eye Treatments	9.1 (±2.6)
	Range = 6 to 14
Treatment Distributions	Artificial Tears = 17 (100.0%)
	Lubricating Ophthalmic Ointment = 17 (100.0%)
	Topical Cyclosporine = 17 (100%)
	Topical Corticosteroids = 16 (94.1%)
	Punctal Occlusion = 13 (76.5%)
	Oral Omega-3 Supplement = 12 (70.6%)
	Warm Compresses and Lid Scrubs = 10 (58.8%)
	Moisture Chamber Goggles, Sleep Masks or other Eyewear Products = 7 (41.2%)
	Topical Lifitegrast = 6 (35.3%)
	Autologous Serum/Blood Products = 6 (35.3%)
	Hydroxypropyl Cellulose Ophthalmic Inserts = 6 (35.3%)
	Eyelid Thermal Pulsation = 5 (29.4%)
	Other Anti-inflammatory Systemics = 5 (29.4%)
	Systemic Cholinergic Agonists = 3 (17.6%)
	Amniotic Membrane Grafting = 2 (11.8%)
	Meibomian Gland Expression = 2 (11.8%)
	Topical Antihistamines = 2 (11.8%)
	Topical Antibiotics = 2 (11.8%)
	Scleral Contact Lenses = 1 (5.9%)
	Liposome Spray = 1 (5.9%)
	Topical Chondroitin Sulfate = 1 (5.9%)
Previous Use of Autologous Serum or other Topical Blood-derived Product	Yes = 6 (35.3%)
	No = 11 (64.7%)
Autoimmune Disorder Diagnosis	Yes = 7 (41.2%)*
	No = 10 (58.8%)
	Sjogren’s Syndrome = 6
	Rheumatoid Arthritis = 2
	Systemic Lupus Erythematosus = 2
	Scleroderma = 1
Other Systemic Disorders	Yes = 6 (35.3%)
	No = 11 (64.7%)
	Thyroid Disorder = 4
	Atopy = 2
	Diabetes Mellitus = 1
	Graft versus Host Disease (GVHD) = 1
Other Ocular Comorbidities	Yes = 3 (17.6%)
	No = 14 (82.4%)
	Herpes Zoster Ophthalmicus = 1
	Floppy Eyelid Syndrome = 1
	Superior Limbic Keratitis = 1
	Salzmann Nodular Degeneration = 1
History of Previous Refractive Surgery	Yes = 4 (LASIK = 4, PRK = 0 and RK = 0) (23.5%)
	No = 13 (76.5%)
Lens Status	Phakic = 12 (70.6%)
	Pseudophakic = 5 (29.4%)

Note: *Some study subjects had multiple diagnoses.

Figure 1 Corneal epithelial stem cell-derived therapy for dry eye disease. Flow chart for enrollment into the clinical trial.

Table 2 Corneal Epithelial Stem Cell-Derived Supernatant for Dry Eye Disease. Average Baseline versus Twelve Week Post-Treatment Outcome Comparisons

Outcomes (n=34 Eyes of 17 Patients)	Average Baseline Values Means with (95% Confidence Intervals)	Post-Treatment Values Means with (95% Confidence Intervals)	p-value
Standardized Patient Evaluation of Eye Dryness (SPEED^TM) Questionnaire (scaled 0 to 28 with 28 being the worst)	20.4 (18.1–22.7)	15.7 (13.4–18.0)	0.0054
Ocular Surface Disease Index (OSDI©) Score (scaled 0 to 100 with 100 being the worst)	63.4 (53.2–73.6)	52.5 (42.0–63.1)	0.1409
Visual Analog Scale (VAS) (scaled 1 to 10 with 10 being the worst)	8.0 (7.3–8.6)	6.8 (6.2–7.5)	0.0202
Best Spectacle Corrected Visual Acuity (logMAR)	0.18 (0.15–0.25)	0.15 (0.07–0.22)	0.5678
Tear Film Osmolarity (mOSM/L)	318.9 (306.6–331.1)	307.3 (294.6–320.0)	0.1884
Topographic Surface Regularity Index (SRI)	0.70 (0.51–0.89)	0.75 (0.55–0.95)	0.7413
Topographic Projected Visual Acuity (PVA) (logMAR)	0.12 (0.08–0.17)	0.13 (0.08–0.18)	0.8673
Average Topographic Surface Asymmetry Index (SAI)	0.81 (0.57–1.05)	1.02 (0.77–1.26)	0.2240

Figure 2 Corneal epithelial stem cell-derived supernatant for dry eye disease. Mean patient reported outcome measurements of over various time intervals during the 12 week treatment period for (A) Standardized Patient Evaluation of Eye Dryness (SPEED^TM) Questionnaire, (B) Ocular Surface Disease Index (OSDI©) Score and (C) Visual Analog Scale (VAS).

Table 3 Corneal Epithelial Stem Cell-Derived Supernatant for Dry Eye Disease. Patient Reported Outcome Measurement Comparisons for Change in Four Week Pre-Treatment Baseline from Immediate Pre-Treatment Baseline versus Change in Immediate Baseline from Average Post-Treatment Values

Outcomes (n=34 Eyes of 17 Patients)	Change in Four Week Pre-Treatment Baseline from Immediate Pre-Treatment Baseline Values Means with (95% Confidence Intervals)	Change in Immediate Pre-Treatment Baseline from Average Post-Treatment Values Means with (95% Confidence Intervals)	p-value
Standardized Patient Evaluation of Eye Dryness (SPEED^TM) Questionnaire	+0.7 (−2.1 to +3.4)	−4.4 (−6.6 to −2.1)	0.0077
Ocular Surface Disease Index (OSDI©) Score	−0.2 (−8.9 to +8.5)	−15.7 (−23.3 to −8.2)	0.0110
Visual Analog Scale (VAS)	−0.15 (−0.75 to +0.45)	−0.98 (−1.48 to −0.49)	0.0372