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Safety and efficacy of a hydroxypropyl guar/polyethylene glycol/propylene glycol-based lubricant eye-drop in patients with dry eye
  1. Marc Labetoulle1,
  2. Elisabeth M Messmer2,
  3. Pierre-Jean Pisella3,
  4. Abayomi Ogundele4,
  5. Christophe Baudouin5
    1. 1Ophthalmology Department, Hôpital Bicêtre, APHP, Paris Saclay University, Kremlin-Bicêtre, France
    2. 2Department of Ophthalmology, Ludwig-Maximilian-University, Munich, Germany
    3. 3Bretonneau Hospital, University of Tours, Tours, France
    4. 4Alcon Research, Ltd., Fort Worth, Texas, USA
    5. 5Quinze-Vingts National Ophthalmology Hospital, Paris, France
    1. Correspondence to Professor Marc Labetoulle, Service d'Ophtalmologie, AP-HP, 78, rue du Général-Leclerc, Le Kremlin-Bicêtre cedex 94725, France; marc.labetoulle{at}vms.cnrs-gif.fr

    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.

    • Clinical Trial
    • Ocular surface
    • Tears
    • Treatment Medical

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