Clinical Ophthalmology (Oct 2020)
Symptom Relief Following a Single Dose of Propylene Glycol-Hydroxypropyl Guar Nanoemulsion in Patients with Dry Eye Disease: A Phase IV, Multicenter Trial
Abstract
Steven Silverstein,1 Elizabeth Yeu,2 Joseph Tauber,3 Michel Guillon,4 Lyndon Jones,5,6 David Galarreta,7 Sruthi Srinivasan,8 Venkiteshwar Manoj8 1Silverstein Eye Centers, Kansas City, MO 64133, USA; 2Virginia Eye Consultants, Norfolk, VA 23502, USA; 3Tauber Eye Center, Kansas City, MO 64155, USA; 4Ocular Technology Group International, London SW1E 6AU, UK; 5Centre for Ocular Research & Education (CORE), School of Optometry and Vision Science, Waterloo, ON NL2 3G1, Canada; 6Centre for Eye and Vision Research Limited (CEVR), Hong Kong; 7Hospital Clinico Universitario de Valladolid, Valladolid Castilla y Leon 47011, Spain; 8Alcon Research, LLC, Johns Creek, GA, USACorrespondence: Steven SilversteinSilverstein Eye Centers, Kansas City, MO 64133, USATel +1 816.358.3600Fax +1 816.358.1887Email [email protected]: 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.Keywords: aqueous-deficient dry eye, dry eye disease, evaporative dry eye, propylene glycol-hydroxypropyl guar nanoemulsion ocular lubricant, mixed dry eye
