NOV03 for Dry Eye Disease Associated with Meibomian Gland Dysfunction: Results of the Randomized Phase 3 GOBI Study.
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Tauber J, Berdy GJ, Wirta DL, Krosser S, Vittitow JL
NOV03 for Dry Eye Disease Associated with Meibomian Gland Dysfunction: Results of the Randomized Phase 3 GOBI Study.
Ophthalmology. 2023 May;130(5):516-524. doi: 10.1016/j.ophtha.2022.12.021. Epub 2022 Dec 24.
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PURPOSE: To evaluate the efficacy and safety of NOV03 (perfluorohexyloctane) ophthalmic drop in patients with dry eye disease (DED) associated with meibomian gland dysfunction (MGD). DESIGN: Eight-week, phase 3, multicenter, randomized, double-masked, saline-controlled study. PARTICIPANTS: Adults >/= 18 years with a history of DED for >/= 6 months, tear film breakup time of /= 5 mm, MGD score >/= 3 (0-15 scale), and total corneal fluorescein staining (tCFS) score >/= 4 and
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