Symptom Relief Following a Single Dose of Propylene Glycol-Hydroxypropyl Guar Nanoemulsion in Patients with Dry Eye Disease: A Phase IV, Multicenter Trial.

Autor: Silverstein S; Silverstein Eye Centers, Kansas City, MO 64133, USA., Yeu E; Virginia Eye Consultants, Norfolk, VA 23502, USA., Tauber J; Tauber Eye Center, Kansas City, MO 64155, USA., Guillon M; Ocular Technology Group International, London SW1E 6AU, UK., Jones L; Centre for Ocular Research & Education (CORE), School of Optometry and Vision Science, Waterloo, ON NL2 3G1, Canada.; Centre for Eye and Vision Research Limited (CEVR), Hong Kong., Galarreta D; Hospital Clinico Universitario de Valladolid, Valladolid Castilla y Leon 47011, Spain., Srinivasan S; Alcon Research, LLC, Johns Creek, GA, USA., Manoj V; Alcon Research, LLC, Johns Creek, GA, USA.
Jazyk: angličtina
Zdroj: Clinical ophthalmology (Auckland, N.Z.) [Clin Ophthalmol] 2020 Oct 09; Vol. 14, pp. 3167-3177. Date of Electronic Publication: 2020 Oct 09 (Print Publication: 2020).
DOI: 10.2147/OPTH.S263362
Abstrakt: Purpose: To evaluate symptom relief in patients with dry eye disease (DED) following a single drop of propylene glycol-hydroxypropyl guar (PG-HPG) nanoemulsion (Systane ® Complete) lubricant eye drops.
Methods: This was a Phase IV, multicenter, open-label, interventional study in adult patients with DED of aqueous-deficient, evaporative, and mixed subtypes. Patients instilled one drop of PG-HPG in each eye at Day 1. Endpoints included change from baseline in dry eye symptom and soothing sensation scores on Day 1 at 0, 4, and 8 hours post-dose. Symptom scores were assessed on a 0-10 scale (0=no symptoms; 10=worst imaginable symptom). Tolerability of the drop was assessed based on assessment score on Day 1 following instillation for overall cohort and by DED subtype.
Results: A total of 134 patients received treatment (mean age: 56.6 years; female: 75.4%). Median changes from baseline at Day 1 in dry eye symptom scores were -1.0 (95% confidence interval [CI]:-3.0,-1.0), -2.0 (95% CI:-3.0,-2.0), and -2.0 (95% CI:-2.0,-1.0) at 0, 4, and 8 hours respectively. Subgroup analysis showed a median change from baseline in dry eye symptom score of -2 (95% CI:-3.0,-1.0) for aqueous-deficient and evaporative subtypes and -1 (95% CI:-3.0,-1.0) for mixed subtype at 8 hours. Median soothing sensation scores were 3 at 0 and 4 hours and 3.5 at 8 hours, with a range of 0-10. Median (range) tolerability assessment scores were 0 (0-8) for burning sensation, stinging sensation, blurring, and 0 (0-10) for foreign body sensation. Tolerability assessment scores by DED subtype confirmed that the majority of patients reported scores in the range of 0-5 for all components and in all subgroups analyzed.
Conclusion: Our study demonstrated that PG-HPG nanoemulsion provided instant/immediate and sustained symptom relief for 8 hours post-single application and was well tolerated in patients with DED, demonstrated by their responses on each of the assessment scales.
Competing Interests: Steven Silverstein: Consultant and research for Alcon. Elizabeth Yeu: Consultant for Alcon, Allergan, Avedro, Avellino, Bausch + Lomb, BioTissue/Tissue Tech, Bruder, BVI, CorneaGen, EyePoint Pharm. Expert Opinion for Glaukos, iOptics, J&J Vision, LENSAR, Kala Pharm., Merck, Mynosys, Novartis, Ocular Science, Ocular Therapeutix, OcuSoft, Omeros Oyster Point Pharm, Science Based Health, Shire, Sun Pharm, TearLab Corp, Carl Zeiss. Investor in Avellino, CorneaGen, Melt, Modernizing Medicine, Mynosys, Ocular Science, Strathspey Crown. Research for Alcon, Allergan, TopCon, AcuFocus. Clinical investigator for Novartis. Joseph Tauber: Research for Alcon. Michel Guillon: Consultant and Financial Support for Alcon and reports grants from Optometric Technology Group Ltd. Lyndon Jones: Consultant and/or serves on an advisory board for Alcon, CooperVision, J&J Vision, Novartis and Ophtecs. Research support or lectureship honoraria from Alcon, Allergan, CooperVision, GL Chemtec, iMed Pharma, J&J Vision, Lubris, Menicon, Nature’s Way, Novartis, Ote, PS Therapy, Safilens, Santen, Shire, SightGlass and Visioneering. David Galarreta: Consultant to Alcon, Bausch + Lomb, Novartis, Santen, Shire, Thea, VISUfarma. Research for Alcon, Allergan, Nicox, Novartis, Sifi. Sruthi Srinivasan and Venkiteshwar Manoj: Employees of Alcon. The authors report no other conflicts of interest in this work.
(© 2020 Silverstein et al.)
Databáze: MEDLINE
Externí odkaz:
Nepřihlášeným uživatelům se plný text nezobrazuje