Clinical evaluation of an oil-based lubricant eyedrop in dry eye patients with lipid deficiency
Eur J Ophthalmol 2017; 27(2): 122 - 128
Article Type: ORIGINAL RESEARCH ARTICLE
AuthorsChristophe Baudouin, David J. Galarreta, Ewa Mrukwa-Kominek, Daniel Böhringer, Vincenzo Maurino, Michel Guillon, Gemma C.M. Rossi, Ivanka J. Van der Meulen, Abayomi Ogundele, Marc Labetoulle
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.
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.
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.
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.
- • Accepted on 01/09/2016
- • Available online on 27/10/2016
- • Published in print on 10/03/2017
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- Baudouin, Christophe [PubMed] [Google Scholar] 1, * Corresponding Author (firstname.lastname@example.org)
- Galarreta, David J. [PubMed] [Google Scholar] 2
- Mrukwa-Kominek, Ewa [PubMed] [Google Scholar] 3
- Böhringer, Daniel [PubMed] [Google Scholar] 4
- Maurino, Vincenzo [PubMed] [Google Scholar] 5
- Guillon, Michel [PubMed] [Google Scholar] 6
- Rossi, Gemma C.M. [PubMed] [Google Scholar] 7
- Van der Meulen, Ivanka J. [PubMed] [Google Scholar] 8
- Ogundele, Abayomi [PubMed] [Google Scholar] 9
- Labetoulle, Marc [PubMed] [Google Scholar] 10
Quinze-Vingts National Ophthalmology Hospital, INSERM-DHOS CIC 1423, Paris - France
University Clinic Hospital of Valladolid, Valladolid - Spain
University Center of Ophthalmology and Oncology, Silesian University of Medicine, Katowice - Poland
Eye Center, University Hospital Freiburg, Freiburg - Germany
Moorfields Eye Hospital, London - UK
Ocular Technology Group-International, London - UK
Clinica Oculistica IRCCS-Policlinico San Matteo, Pavia - Italy
Academic Medical Center, Amsterdam - The Netherlands
Alcon Research, Ltd., Fort Worth, TX - USA
Ophthalmology Department, Bicêtre University Hospital, South Paris University, Kremlin-Bicêtre - France