title: Safety and efficacy of a hydroxypropyl guar/polyethylene glycol/propylene glycol-based lubricant eye-drop in patients with dry eye.
abstract: 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.
  
  
  
  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.
  
  
  
  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).
  
  
  
  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.
  
  
  
  NCT01863368, Results.
authors.affiliation: Ophthalmology Department, Hôpital Bicêtre, APHP, Paris Saclay University, Kremlin-Bicêtre, France.
authors.forename: Marc
authors.initials: M
authors.lastname: Labetoulle
authors.affiliation: Department of Ophthalmology, Ludwig-Maximilian-University, Munich, Germany.
authors.forename: Elisabeth M
authors.initials: EM
authors.lastname: Messmer
authors.affiliation: Bretonneau Hospital, University of Tours, Tours, France.
authors.forename: Pierre-Jean
authors.initials: PJ
authors.lastname: Pisella
authors.affiliation: Alcon Research, Ltd., Fort Worth, Texas, USA.
authors.forename: Abayomi
authors.initials: A
authors.lastname: Ogundele
authors.affiliation: Quinze-Vingts National Ophthalmology Hospital, Paris, France.
authors.forename: Christophe
authors.initials: C
authors.lastname: Baudouin
mesh_terms: D015352:Dry Eye Syndromes / Q000188:drug therapy* / Q000503:physiopathology; D005260:Female; D005602:France; D005858:Germany; D006801:Humans; D054327:Lubricants / Q000494:pharmacology / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009883:Ophthalmic Solutions / Q000494:pharmacology / Q000627:therapeutic use*; D011092:Polyethylene Glycols / Q000494:pharmacology / Q000627:therapeutic use*; D011134:Polysaccharides / Q000494:pharmacology / Q000627:therapeutic use*; D019946:Propylene Glycol / Q000494:pharmacology / Q000627:therapeutic use*; D011446:Prospective Studies; D013501:Surface-Active Agents / Q000494:pharmacology / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D054327:Lubricants; D009883:Ophthalmic Solutions; D011134:Polysaccharides; D013501:Surface-Active Agents; C519976:hydroxypropyl guar; D011092:Polyethylene Glycols; D019946:Propylene Glycol
keywords: Clinical Trial; Ocular surface; Tears; Treatment Medical