A perfluorohexyloctane ophthalmic drop, NOV03, was shown to significantly improve dry eye signs and symptoms in patients with meibomian gland disease (MGD) according to these results from the phase 3 MOJAVE clinical study.
Study design
This phase 3, randomized, multicenter, double-masked trial compared NOV03 (MIEBO, perfluorohexyloctane ophthalmic solution) to a control solution of hypotonic saline (0.6% NaCl, preserved with 0.01% benzalkonium chloride) for the treatment of dry eye disease related to MGD. Six hundred twenty patients with dry eye disease and signs of MGD were randomized to each treatment group and were instructed to administer 1 drop 4 times daily for 8 weeks. Primary endpoints included clinical signs (corneal staining) and patient symptoms (eye dryness, burning/stinging), which were assessed at screening, baseline (day 1), and follow-up visits at week 2, week 4, and week 8.
Outcomes
Statistically significant improvement was seen in both primary endpoints at weeks 2, 4, and 8. At week 8, 50.0% of NOV03 patients showed >3 steps of improvement in corneal staining (vs 30.7% in the control group), and 65.6% of NOV03 patients showed >30% improvement in dry-eye symptoms (vs. 45.3% of the control group). Adverse events were similarly reported by each group.
Limitations
The short duration of follow-up is one limitation, but a 12-month study of NOV3 is due to follow. The inclusion of benzalkonium chloride in the saline eye drops may also have affected study results. However, the authors note that the concentration was 0.01%, and the relatively short duration of exposure to benzalkonium chloride may limit any confounding effect.
Clinical significance
Dry eye disease is one of the most persistent and common conditions seen in eye care. This study suggests that NOV03 may provide an effective treatment when it comes to providing symptomatic relief in patients with dry eye disease, especially relating to MGD.
Financial Disclosures: Dr. Daniel Choi discloses financial relationships with Glaukos Corporation (Lecture Fees/Speakers Bureau); Kala Pharmaceuticals (Consultant/Advisor).