Safety and efficacy of a hydroxypropyl guar/polyethylene glycol/propylene glycol-based lubricant eye-drop in patients with dry eye. Issue 4 (15th July 2016)

• Record Type: Journal Article
• Authors: Labetoulle, Marc; Messmer, Elisabeth M; Pisella, Pierre-Jean; Ogundele, Abayomi; Baudouin, Christophe
• Other Names: Baillif-Gostoli Stéphanie author non-byline.; Bohringer Daniel author non-byline.; Chiambaretta Fredéric author non-byline.; Cochener Béatrice author non-byline.; Gabison Eric author non-byline.; Gabisson Pierre author non-byline.; Girard Brigitte author non-byline.; Gohier Philippe author non-byline.; Moremousque Bruno author non-byline.; Mouriaux Fredéric author non-byline.; Touboul David author non-byline.; Ziemssen Focke author non-byline.
• Is Part Of: British journal of ophthalmology. Volume 101:Issue 4(2017)
• Page Start: 487
• Page End: 492
• Publication Date: 2016-07-15
• Subjects: Clinical Trial -- Ocular surface -- Tears -- Treatment Medical; Ophthalmology -- Periodicals; 617.7
• DOI: 10.1136/bjophthalmol-2016-308608
• Languages: English
• ISSNs: 0007-1161

Abstract

Abstract : Aims: To demonstrate non-inferiority of a hydroxypropyl guar/polyethylene glycol/propylene glycol lubricating eye-drop (HPG/PEG/PG) compared with an osmoprotective carboxymethylcellulose/glycerine eye-drop (O/CMC) for ocular surface staining. Methods: This was a multicentre, randomised, observer-masked, parallel-group study. Adults with dry eye instilled HPG/PEG/PG/ or O/CMC 4 times daily for 35 days and then as needed through day 90. Total ocular surface staining (TOSS) score changes from baseline and Impact of Dry Eye on Everyday Life (IDEEL) treatment satisfaction module scores were assessed. Non-inferiority, based on TOSS score change from baseline, was concluded if the upper limit of the 2-sided CI was <2 units. Results: Mean±SD patient age was 64.4±13.7 years; 94 patients were randomised to treatment (HPG/PEG/PG, n=46; O/CMC, n=48). Mean±SE TOSS score change from baseline to day 35 was −2.2±0.33 with HPG/PEG/PG and −1.7±0.47 with O/CMC (treatment difference, −0.47±0.47; p=0.38), and the non-inferiority criterion was met. IDEEL treatment satisfaction scores were similar between groups at day 35 and day 90. The most frequently reported adverse event was eye irritation (HPG/PEG/PG, n=2; O/CMC, n=3). Conclusions: HPG/PEG/PG and O/CMC reduced ocular surface damage, and HPG/PEG/PG was non-inferior to O/CMC. Both treatments were effective, convenient and well tolerated. Trial registration number: NCT01863368, Results.