1. In a signifier 3 randomized controlled proceedings of astir 600 patients with adust oculus disease, NOV03, a perfluorohexyloctane oculus drop, was associated with importantly little fluorescein staining connected introspection and self-reported dryness scores than saline drops astatine 8 weeks of treatment.
2. NOV03 was besides associated with important betterment compared to saline drops aft 2 weeks of attraction based connected some exam-based fluorescein scores and self-reported dryness scores.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Dry oculus illness is an highly common, multifactorial ocular information that tin origin irritation, blurred vision, and reduced prime of life. Meibomian gland dysfunction (MGD), deficiency oregon alteration successful fatty secretions that signifier the teardrop film, contributes to astir cases of adust oculus disease. Currently, adust oculus therapy is centered astir artificial tears, lukewarm compresses, and immune-directed oculus drops that bash not specifically people MGD. This signifier 3 randomized proceedings including 597 patients aimed to measure the efficacy of NOV03, a perfluorohexyloctane oculus driblet that is thought to signifier a furniture that preserves the teardrop film, successful patients with MGD-associated adust eyes. Compared to patients utilizing saline drops, patients utilizing NOV03 had importantly little fluorescein staining connected exam by 0.97 points connected a standard of 15, indicating betterment successful adust eye, arsenic good arsenic self-reported betterment successful dryness by 7.6 retired of 100 points aft 8 weeks of treatment. NOV03 was besides associated with importantly greater betterment successful some exam-based and self-reported scores than saline drops astatine some 2 week and 8 week timepoints. This proceedings provides convincing grounds of a humble but meaningful physiological and symptomatic payment of this caller medicine for patients with adust oculus illness driven by MGD. The survey included lone patients with important adust oculus symptoms lasting astatine slightest 6 months and important MGD based connected exam, truthful further survey successful broader populations with adust oculus symptoms volition beryllium indispensable to find which patients are apt to benefit.
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Relevant Reading: Modern attack to the attraction of adust eye, a analyzable multifactorial disease: A P.I.C.A.S.S.O. committee review
In-Depth [randomized controlled trial]: Adults with symptomatic adust oculus illness astatine 26 centers successful the United States were included betwixt 2019 and 2021. Among the inclusion criteria were teardrop break-up clip of 5 seconds oregon little and MGD people supra 3 connected a standard from 0 to 15. The survey was double-masked; patients successful the power radical received hypotonic saline drops. Patients did not usage artificial tears oregon interaction lenses during the trial. Subjects were randomized successful a 1:1 ratio stratified by tract and baseline adust oculus severity. One driblet of NOV03 oregon saline was utilized 4 times per time for 8 weeks. Fluorescein staining scores were based connected doc standing connected a standard from 0 to 3 astatine each of 5 corneal sites. The superior intention-to-treat investigation utilized hierarchical fixed investigating connected a predefined series of endpoints. At 8 weeks, the least-squares (LS) mean attraction quality successful corneal fluorescein staining scores was -0.97 [95% assurance interval (CI) -1.40 to -0.55; p<0.001], and successful dryness scores was -7.6 (95% CI -11.8 to -3.4; p<0.001). At 2 weeks, the LS mean attraction quality successful fluorescein staining scores was -0.6 (95% CI -0.9 to -0.2; p=0.001) and successful dryness scores was -4.7 (-8.2 to -1.2; p=0.009).
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