July 2019
Volume 60, Issue 9
Open Access
ARVO Annual Meeting Abstract  |   July 2019
Evaluation of eyelid cleansing products for meibomian glands dysfunction management in dry eye symptomatic patients through two parallel clinical studies
Author Affiliations & Notes
  • Camille Guerin
    Horus Pharma, Saint Laurent du Var, France
  • Laure Chauchat
    Horus Pharma, Saint Laurent du Var, France
  • MARTINE CLARET
    Horus Pharma, Saint Laurent du Var, France
  • Claude Claret
    Horus Pharma, Saint Laurent du Var, France
  • Footnotes
    Commercial Relationships   Camille Guerin, Horus pharma (E); Laure Chauchat, Horus pharma (E); MARTINE CLARET, Horus Pharma (E); Claude Claret, Horus Pharma (E)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science July 2019, Vol.60, 6743. doi:https://doi.org/
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      Camille Guerin, Laure Chauchat, MARTINE CLARET, Claude Claret; Evaluation of eyelid cleansing products for meibomian glands dysfunction management in dry eye symptomatic patients through two parallel clinical studies. Invest. Ophthalmol. Vis. Sci. 2019;60(9):6743. doi: https://doi.org/.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : The objective of these two parallel studies was to quantify the effects of highly concentrated sodium hyaluronate preservative free (PF) cleansing wipes and gel on symptomatic dry eye patients with meibomian glands dysfunction (MGD).

Methods : Each assay was designed as a single arm, open label, interventional study with a bilateral use of tested products over one-month duration. Both studies were performed in parallel on a total of 60 symptomatic dry eye patients (2x30) in order to compare the effect of a twice daily eyelid cleansing by wipes or gel. Both tested products were a PF formulation containing a combination of sodium hyaluronate and allantoin. Key inclusion criteria were dry eye patients >18 years old with lid margin anomalies as MGD and/or anterior blepharitis. The products efficacy was assessed through evaluation of symptomatology, meibomian gland status and corneal, conjunctival and palpebral tissues by comparing data collected at baseline (visit 1) to data recorded after a 30-day treatment (visit 2). The following statistical tests were used for the analysis: t-test, ANOVA, Wilcoxon (p=0.05). Safety was assessed through an ocular integrity evaluation at each visit using slit lamp biomicroscopy.

Results : An average significant decrease in meibomian gland blockage (27%, 26%), and an increase in the proportion of clean eyelashes (20%, 17%) were observed at visit 2 for cleansing wipes and gel respectively. Further, an improvement in the status of the lid margin and a significant decrease in overall symptomatology as evidenced by a decrease in OSDI mean score (24%, 38%) were also reported after one month. Moreover, the related OSDI mean score was classified as severe at baseline whereas it dropped to moderate after using tested products over one month. Besides, the significant increase in ocular comfort ratings upon waking (37%,23%) and in the evening (31%, 33%) confirmed the efficacy of the eyelid cleansing wipes and gel respectively. Only minor safety issues were reported on 2 patients (eyelid margin irritation, resolved after stopping).

Conclusions : Data collected over these one-month treatment periods demonstrated efficacy and safety of twice daily use of highly concentrated sodium hyaluronate PF cleansing wipes and gel in managing lid margin anomalies and improving ocular comfort of dry eye patients with eyelid anomalies.

This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.

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