Semifluorinated Alkane Eye Drops for Treatment of Dry Eye Disease Due to Meibomian Gland Disease

Philipp Steven, Albert J Augustin, Gerd Geerling, Thomas Kaercher, Florian Kretz, Kathleen Kunert, Johannes Menzel-Severing, Norbert Schrage, Wolfgang Schrems, Sonja Krösser, Michael Beckert, Elisabeth M Messmer, Philipp Steven, Albert J Augustin, Gerd Geerling, Thomas Kaercher, Florian Kretz, Kathleen Kunert, Johannes Menzel-Severing, Norbert Schrage, Wolfgang Schrems, Sonja Krösser, Michael Beckert, Elisabeth M Messmer

Abstract

Purpose: Meibomian gland disease is generally accepted as the leading cause for evaporative dry eye disease (DED). In a previous study, perfluorohexyloctane, a semifluorinated alkane, has been demonstrated to significantly increase tear film breakup time and to reduce corneal fluorescein staining in patients with evaporative DED, thereby vastly reducing dry eye-related symptoms. This study was set up to evaluate perfluorohexyloctane in a larger population of patients with Meibomian gland dysfunction.

Methods: Seventy-two patients with Meibomian gland disease and associated dry eye received 1 drop of perfluorohexyloctane 4 times daily during an observational, prospective, multicenter, 6-8-week study. Clinical assessment included best-corrected visual acuity, intraocular pressure, Schirmer test I, tear film breakup time, anterior and posterior blepharitis assessment, number of expressible Meibomian glands, meibum quality and quantity, ocular surface fluorescein staining, lid margin and symptom assessment, and Ocular Surface Disease Index (OSDI©).

Results: From the 72 patients recruited, 61 completed the trial per protocol. Nine patients did not apply the medication as recommended and 2 patients were lost to follow-up. Tear film breakup time, corneal and conjunctival fluorescein staining, number of expressible Meibomian glands, and severity of anterior and posterior blepharitis significantly improved after 6-8 weeks of perfluorohexyloctane application. In addition, symptoms improved as demonstrated by a significant decrease of OSDI-values from 37 (±13) to 26 (±16).

Conclusions: In concordance with previous findings, 6-8 weeks of topical application of perfluorohexyloctane significantly improves clinical signs of Meibomian gland disease and associated mild to moderate DED.

Trial registration: ClinicalTrials.gov NCT02356341.

Keywords: Meibomian gland disease; blepharitis; dry eye disease; semifluorinated alkanes.

Conflict of interest statement

P.S.: received grants by Novaliq GmbH. T.K.: Consultant to Novaliq. N.S.: Consultant and research contracts for Novaliq GmbH. S.K.: Employee of Novaliq GmbH. M.B.: Clinical Development Consultant to Novaliq. All other authors have no competing financial interests.

Figures

FIG. 1.
FIG. 1.
Blepharitis assessment. The graphics demonstrate changes of blepharitis severity from baseline to follow-up. Improvement is visible by shift from higher to lower severity grades of anterior and posterior blepharitis (data set: PPP, n = 122 eyes). PPP, per-protocol population.
FIG. 2.
FIG. 2.
Meibum assessment. The graphics demonstrate improvement of meibum quality (A), only little change in meibum quantity (B), and reduction in necessary pressure for meibum expression (C). Data set: PPP, n = 122 eyes).

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