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Judith Flanagan, Nisha Yeotikar, Jennie Diec, Daniel Tilia; Safety and efficacy of a novel ocular comfort agent: Interim analysis. Invest. Ophthalmol. Vis. Sci. 2019;60(9):6756.
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© ARVO (1962-2015); The Authors (2016-present)
To determine the safety (phase I) and efficacy (phase II) of novel application around the eye of an OTC wellness agent containing glycerol monolaurate (GML) in reducing signs and symptoms of dry eye and MGD.
Phase 1: 10 subjects (normal ocular and general health) were enrolled in a prospective, randomized, contralateral, double-masked study comparing safety of GML ointment and Vaseline (control) with 6 visits over 3 days and washout of two nights for crossover. After 10min, 3h and 6h application each day, bulbar and limbal conjunctival redness, corneal staining and subjective ocular comfort score were recorded. Phase II: 18 subjects with mild to severe dry eye were enrolled and randomly allocated to control or treatment groups. Inclusion criteria included ODSI score >12 and at least one expressible meibomian gland. Subjects were assessed at 4 visits: Baseline, Wk1, Wk3 and Wk6 at which the following signs and symptoms were scored: OSDI, ocular comfort, meibum quality (MQ) and MG expressibility (MGE) of the lower lid, lid margin and lash appearance, conjunctival redness and roughness, fluorescein tear break-up-time (FBUT), and corneal and conjunctival staining.
Phase l: No adverse events were noted with control or treatment. There was no significant change in bulbar or limbal conjunctival redness, corneal staining or subjective ocular comfort score after 3h or 6h, and no significant difference for any outcome variables between the test and control ointments at any study visit. Phase ll: Significant improvement (relative to baseline) after 3 or 6 weeks’ use of GML ointment relative to control comprised: reductions in blepharitis at Wk3 (p=0.038) and Wk6 (p=0.001); reductions limbal conjunctival redness Wk6 (p=0.001), improvements in MQ at Wk3 (p=0.0031) and Wk6 (p=0.003), and improvement in MGE at Wk6 (p=0.008).
Novel topical (around the eyelid area) application of GML ointment was shown to be safe. Further, these initial data indicate a potential positive effect of GML in reducing signs of dry eye disease. Further analysis upon completion of the study will determine whether these initial positive indications are realised in the larger cohort.
This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.
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