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R. Vogel, T.R. Walters, L. Molina, T.W. Laliberte, S.J. Augello–Vaisey, L.H. Butler, T.M. Lehman; Ocular Safety and Tolerability of Two Doses of Moli1901 Ophthalmic Solution in Healthy Subjects . Invest. Ophthalmol. Vis. Sci. 2006;47(13):5595.
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A Phase 1 study comparing the safety and tolerability of Moli1901 Ophthalmic Solution in 0.05% and 0.1% concentrations with the vehicle and with saline. Moli1901 is a Type B lantibiotic that is being investigated for the treatment of dry eye. This compound is considered a "secretagogue" because it stimulates secretion of water and chloride by the epithelium.
A single center, randomized, double–masked, placebo–controlled, parallel–group, ascending dose study in a total of 30 adult healthy volunteer subjects who received either saline placebo (n = 6); vehicle (n = 8); Moli1901 0.05% (n = 8); or Moli1901 0.1% (n = 8). Subjects were dosed in both eyes QID for 14 days (except for baseline and Day 14 of treatment, when only 3 doses were instilled); follow–up evaluations were conducted the day following the last dose of study medication and 2 weeks after the last dose. The principal determinants of tolerability and safety were subjective reports of symptomatology and objective findings on the slit lamp examination plus corneal fluorescein staining.
There were no serious ocular or systemic adverse events. Twenty–four subjects (80%) reported at least one treatment–related adverse event, the majority of which were mild. Treatment–emergent adverse events judged possibly or probably related to treatment were predominantly eye related. The most frequently reported adverse events were corneal staining, conjunctival injection, and eye irritation. Corneal staining appeared to be dose related. Plasma samples analyzed for presence of Moli1901 were below the limits of quantitation, indicating there was no detectable systemic exposure from topical administration of 0.1% Moli1901 QID OU.
Study results suggested that ocular administration of Moli1901 0.05% and 0.1% QID for 14 days was safe and well tolerated in healthy subjects. Further investigation in subsequent clinical trials is indicated. Evaluation of Moli1901 in subjects with dry eye using doses less than 0.1% QID for up to 4 weeks is supported by these results.
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