A Water-Free Omega-3 Fatty Acid Eye Drop Formulation for the Treatment of Evaporative Dry Eye Disease: A Prospective, Multicenter Noninterventional Study

Abstract

Purpose: NovaTears®+Omega-3 is a water-free eye drop solution with non-animal-derived omega-3 fatty acids. It allows to supplement omega-3 fatty acids directly in the tear film of patients with dry eye disease (DED). This post-market clinical follow-up (PMCF) study evaluated for the first time the effects on clinical signs and patient symptoms of DED, and safety and tolerability of NovaTears+Omega-3 (0.2%) eye drops, when used in accordance with its approved label. Methods: A prospective, multicenter, single-arm, uncontrolled, open-label observational cohort study was performed in patients suffering from symptoms of evaporative DED. Patients were treated 4 times daily bilaterally according to the instructions for use for 8 weeks, and standard of care clinical end points were assessed at baseline and follow-up. The trial was conducted at 2 investigational sites in Germany, Europe. Results: Thirty-six patients were included and 33 completed the study. NovaTears+Omega-3 (0.2%) showed clinically and statistically significant improvements in various clinical signs, such as total corneal staining, tear film break-up time, and Meibomian gland dysfunction (MGD) score, as well as in symptoms measured by Ocular Surface Disease Index (OSDI©) and visual analog scales over the 8-week treatment period with change from baseline P values all <0.0001. No worsening of any safety parameter (intraocular pressure, slit-lamp examination, visual acuity) was observed, and no adverse event was reported throughout the study. Conclusions: In this observational PMCF study, NovaTears+Omega-3 was safe and well tolerated. Treatment over an 8-week period resulted in significantly improved clinical signs and subjective symptoms in patients with evaporative dry eye. The study was registered at www.clinicaltrials.gov (NCT04521465).

Keywords: DED; PMCF; dry eye disease; keratoconjunctivitis sicca; omega-3 fatty acid; perfluorohexyloctane.

Conflict of interest statement

C.J. and T.K. received research grants for the study. S.A-M. and A.L. are employees of Novaliq GmbH.

Figures

FIG. 1.

Mean tCFS at baseline and week 8. High statistically significant difference for CFB in tCFS at week 8 (P < 0.001). The NEI scale divides the cornea into 5 regions. The total score is the sum of all regions (0–3 per region, total score of 15 indicates maximum staining). CFB, change from baseline; NEI, National Eye Institute; tCFS, total corneal fluorescein staining.

FIG. 2.

TBUT over the treatment period. Difference for CFB at week 8 (P < 0.0001). TBUT, tear film break-up time.

FIG. 3.

MGD score over treatment period. High statistically significant difference for CFB at week 8 (P < 0.0001). Five central glands on lower eyelid were evaluated, each scored from 0 to 3; 0 = normal; 1 = thick/yellow, whitish, particulate; 2 = paste; 3 = none/occluded; the total MGD score ranged from 0 to 15. MGD, Meibomian gland dysfunction.

FIG. 4.

Mean change from baseline (±SEM) for VAS dryness symptoms over the treatment period. High statistically significant difference for CFB at week 8 (P < 0.0001). SEM, standard error of the mean; VAS, visual analog scale.

FIG. 5.

OSDI score over treatment period. High statistically significant difference for CFB at week 8 (P < 0.0001). OSDI, Ocular Surface Disease Index.

FIG. 6.

Schirmer's test I over treatment period. Scores remain nearly the same as expected for a population with evaporative DED and normal scores at baseline. DED, dry eye disease.