title: Clinical evaluation of an oil-based lubricant eyedrop in dry eye patients with lipid deficiency.
abstract: OBJECTIVE
  To evaluate and compare the efficacy of a lipid-based lubricant eyedrop formulation (hydroxypropyl guar/propylene glycol/phospholipid [HPG/PG/PL]) with preservative-free saline for the treatment of dry eye.
  
  
  METHODS
  This was a prospective, multicenter, randomized, single-masked, parallel-group phase 4 clinical study. Patients ≥18 years diagnosed with dry eye received 1 drop of saline 4 times daily (QID) for 15 days during a run-in phase, followed by randomization. Patients then instilled HPG/PG/PL or saline QID through day 35 and as needed through day 90. Change in tear film break-up time (TFBUT), change in total ocular surface staining (TOSS) score, and Impact of Dry Eye on Everyday Life (IDEEL) were evaluated on day 35.
  
  
  RESULTS
  Increase in TFBUT from baseline to day 35 was assessed during the interim and final analyses. Mean ± SE difference between the HPG/PG/PL (n = 110) and saline groups (n = 100) was 1.3 ± 0.4 seconds (interim analysis; 95% confidence interval [CI] 0.5-2.1 seconds; p = 0.0012) and 1.0 ± 0.3 seconds (final analysis; 95% CI 0.4-1.6 seconds; p = 0.0011), demonstrating the superiority of HPG/PG/PL. The mean ± SE difference between the HPG/PG/PL and saline groups for IDEEL treatment effectiveness scores was 16.0 ± 3.6 (95% CI 8.9-23.1; p<0.0001). No significant differences in TOSS scores or IDEEL inconvenience scores were observed between treatment groups.
  
  
  CONCLUSIONS
  Thirty-five days of QID HPG/PG/PL treatment resulted in a statistically significant improvement in TFBUT and IDEEL treatment effectiveness scores compared with saline but not in TOSS or IDEEL treatment inconvenience scores. HPG/PG/PL was well-tolerated by patients.
authors: Quinze-Vingts National Ophthalmology Hospital, INSERM-DHOS CIC 1423, Paris - France.
authors: Christophe
authors: C
authors: Baudouin
authors: University Clinic Hospital of Valladolid, Valladolid - Spain.
authors: David J
authors: DJ
authors: Galarreta
authors: University Center of Ophthalmology and Oncology, Silesian University of Medicine, Katowice - Poland.
authors: Ewa
authors: E
authors: Mrukwa-Kominek
authors: Eye Center, University Hospital Freiburg, Freiburg - Germany.
authors: Daniel
authors: D
authors: Böhringer
authors: Moorfields Eye Hospital, London - UK.
authors: Vincenzo
authors: V
authors: Maurino
authors: Ocular Technology Group-International, London - UK.
authors: Michel
authors: M
authors: Guillon
authors: Clinica Oculistica IRCCS-Policlinico San Matteo, Pavia - Italy.
authors: Gemma C M
authors: GC
authors: Rossi
authors: Academic Medical Center, Amsterdam - The Netherlands.
authors: Ivanka J
authors: IJ
authors: Van der Meulen
authors: Alcon Research, Ltd., Fort Worth, TX - USA.
authors: Abayomi
authors: A
authors: Ogundele
authors: Ophthalmology Department, Bicêtre University Hospital, South Paris University, Kremlin-Bicêtre - France.
authors: Marc
authors: M
authors: Labetoulle
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015352:Dry Eye Syndromes / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology; D004655:Emulsions; D005260:Female; D006801:Humans; D008055:Lipids / Q000172:deficiency*; D065346:Lubricant Eye Drops / Q000008:administration & dosage* / Q000737:chemistry; D008297:Male; D008875:Middle Aged; D010715:Phosphatidylglycerols / Q000008:administration & dosage / Q000737:chemistry; D011134:Polysaccharides / Q000008:administration & dosage / Q000737:chemistry; D011310:Preservatives, Pharmaceutical; D019946:Propylene Glycol / Q000008:administration & dosage / Q000737:chemistry; D011446:Prospective Studies; D011788:Quality of Life / Q000523:psychology; D016037:Single-Blind Method; D013666:Tears / Q000502:physiology; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D004655:Emulsions; D008055:Lipids; D065346:Lubricant Eye Drops; D010715:Phosphatidylglycerols; D011134:Polysaccharides; D011310:Preservatives, Pharmaceutical; C519976:hydroxypropyl guar; D019946:Propylene Glycol; C002773:dimyristoylphosphatidylglycerol