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Philipp Steven, Bernhard Guenther, Dieter Scherer, Michael Beckert, Claus Cursiefen, Thomas Kaercher; Semifluorinated Alkane Eye Drops for Treatment of Dry-Eye Disease - A Prospective, Multicenter, Non Interventional Study. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):4493.
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© ARVO (1962-2015); The Authors (2016-present)
Evaporation and meibomian gland dysfunction are heavily discussed as core reasons for dry eye disease (DED). Recently the novel substance perfluorohexyloctane (F6H8), a semifluorinated alkane (SFA), has been introduced as a non-blurring, preservative-free wetting agent that reduces shearing forces between surfaces and enables to bind lipids due to its lipophilic nature without the necessity to form water-oil suspensions. After successful pre-clinical testing F6H8 has been marked as a medical device (NovaTears®) and was used in a treatment survey in patients with mild to moderate DED.
30 Patients with evaporative DED were included in an open, prospective, uncontrolled post-market clinical follow-up study and, after providing their informed consent, applied 4 times daily in both eyes for 6 weeks. Clinical examination included visual acuity, intraocular pressure (IOP), Schirmer I, tearfilm break-up time (TFBUT), corneal fluorescein staining and meibum secretion, etc. In addition each patient completed a questionnaire similar to the Ocular surface disease index (OSDI©).
Visual acuity and IOP did not change over time, Schirmer I increased significantly from 10.3 (+/- 3.9) to 16.2 (+/- 9.1) P =0.0011 (mean of both eyes). TFBUT increased significantly from 6.0 (+/- 2.5) to 8.8 (+/- 4.9) P = 0.0026 in the right eye and from 5.8 (+/- 2.6) to 9.6 (+/- 5.9) P = 0.0006 in the left eye, respectively. Ocular surface staining decreased significantly (P = 0.0013 in the right eye and P = 0.0041 in the left eye and OSDI decreased from 55 (+/- 23) to 34 (+/- 22) P < 0.0001 (mean of both eyes). Symptoms such as redness, itching, etc. improved whereas meibum quality only improved in some patients. A total of five Adverse Events were reported from which two were unrelated to the substance tested, two likely related and one related demonstrating a mild hypersensitivity which resolved immediately following discontinuation of the application.
This first prospective treatment survey of NovaTears® shows beneficial effects in patients suffering from hyperevaporative DED. In particular, tearfilm stability and tear production increased, while corneal staining and OSDI score decreased significantly. NovaTears® was well tolerated and the low number of adverse events demonstrate a safe application of this new type of unpreserved artificial tear in evaporative DED.
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