A novel perfluorohexyloctane drop (NOV03) free of water and preservatives can significantly reduce signs and symptoms of dry eye disease (DED) in individuals with signs of meibomian gland dysfunction (MGD), according to a study in the American Journal of Ophthalmology.
Investigators enrolled 620 individuals with DED associated with MGD in a randomized, double-masked, multicenter, phase 3 clinical trial and randomly assigned participants to treatment with the novel perfluorohexyloctane drops (n=302) or saline (n=296). Participants underwent treatment 4 times daily during the 8-week study duration and attended follow-up visits at 2, 4, and 8 weeks following a screening and baseline assessment. The team assessed DED symptoms using visual analog scale (VAS) dryness score (0, no discomfort; 100, maximum discomfort), and signs using total corneal fluorescein staining (tCFS) score.
Participants treated with the novel perfluorohexyloctane drop experienced significantly greater reductions in both tCFS (-2.3 vs -1.1; least squares [LS] mean treatment difference, -1.2; 95% CI, -1.7 to -0.8; P <.001) and VAS dryness scores (-29.4 vs -19.2; LS mean treatment difference, -10.2; 95% CI, -14.4 to -6.1; P <.001) from baseline compared with patients who underwent saline control treatment. Significant differences between the 2 treatment methods were noted in as little as 2 weeks, the report shows.
Adverse ocular events were comparable among individuals treated with the novel perfluorohexyloctane drop and saline solution (12.9% vs 12.3%), and no adverse events led to treatment discontinuation. Investigators determined that these adverse events were related to treatment in 6.4% and 6.8% of individuals in the novel perfluorohexyloctane drop treatment and control groups, respectively.
Treatment with the novel perfluorohexyloctane drops has improved both signs and symptoms of DED in 3 randomized, double-masked, saline–controlled trials, which include the GOBI (ClinicalTrials.gov Identifier: NCT04139798), MOJAVE (ClinicalTrials.gov Identifier: NCT04567329) and SEECASE (ClinicalTrials.gov Identifier: NCT03333057) studies. “These findings are noteworthy, given that demonstration of consistent treatment benefits for both signs and symptoms of DED in repeated clinical studies has not been shown to date for currently approved prescription DED therapies,” according to the researchers.
Study limitations include the exclusion of patients with severe dry eye and a short study duration.
Disclosure: This research was supported by Bausch + Lomb. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Sheppard J, Kurata F, Epitropoulos AT, Krösser S, Vittitow, JL. NOV03 for signs and symptoms of dry eye disease associated with meibomian gland dysfunction: the randomized phase 3 MOJAVE study. Am J Ophthalmol. Published online March 20, 2023. doi:10.1016/j.ajo.2023.03.008