PURPOSE: To evaluate the efficacy and safety of NOV03 (perfluorohexyloctane) ophthalmic drop for the treatment of signs and symptoms of dry eye disease (DED) associated with meibomian gland dysfunction (MGD).

DESIGN: Randomized, double-masked, controlled trial.

METHODS: Patients =18 years of age with a history of DED and signs of MGD were randomly assigned 1:1 to treatment with NOV03 or hypotonic saline (0.6%) 4 times daily for 8 weeks. The primary sign and symptom endpoints were change from baseline to week 8 in total corneal fluorescein staining (tCFS; National Eye Insti- tute scale) and eye dryness score (0-100 visual analog scale), respectively.

RESULTS: A total of 620 patients (NOV03, n = 311; saline, n = 309) were randomized and treated. Least- squares (LS) mean change from baseline to week 8 was statistically significantly greater for NOV03 compared with saline for both tCFS ( -2.3 vs -1.1; LS mean treat- ment difference, -1.2 [95% confidence interval -1.7 to -0.8]; P < .001) and visual analog scale dryness score ( -29.4 vs -19.2; LS mean treatment difference, -10.2 [95% CI -14.4 to -6.1]; P < .001), with statistically significant between-group differences observed as early as week 2. The incidence of ocular adverse events was simi- lar for NOV03 (12.9%) and saline (12.3%). There were no serious adverse events and no adverse events leading to treatment discontinuation.

CONCLUSIONS: In this randomized controlled trial of patients with DED associated with MGD, NOV03 sig- nificantly reduced both signs and symptoms of DED compared with hypotonic saline control. NOV03 was well tolerated, with an adverse event profile similar to that of saline.