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Clinical evaluation of an oil-based lubricant eyedrop in dry eye patients with lipid deficiency

Abstract

Purpose

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.

Eur J Ophthalmol 2017; 27(2): 122 - 128

Article Type: ORIGINAL RESEARCH ARTICLE

DOI:10.5301/ejo.5000883

Authors

Christophe 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

Article History

Disclosures

Informed consent: The study was conducted in accordance with the Declaration of Helsinki and the International Conference on Harmonisation Good Clinical Practice standards. Participants provided voluntary written informed consent at screening. The study protocol received institutional review board approval from Comité de Protection des Personnes Île-de-France 8 at Hopital Ambroise Paré; Ethik-Kommission der Albert-Ludwigs-Universität Freiburg; Ethik-Kommission bei der Landesärztekammer Rheinland-Pfalz; Ethik-Kommission der Arztekammer Westfalen-Lippe und der Medizinischen Fakultat der Westfaalischen Willhelms-Universität; Ärztekammer des Saarlandes Ethik-Kommission; Comitato Etico per la Sperimentazione Clinica Azienda Ospedaliera di Padova; Comitato Etico per la Sperimentazione Clinica AOU Integrata di Verona; Comitato Etico Interaz Milano Area A; Comitato Etico Fondazione IRCCS Policinico San Matteo; METC AMC Amsterdam; Komisja Bioetyczna Slaskiego Uniwersytetu Medycznego; Comité Ético de Investigación Clínica Area de Salud de Vallodolid Este Hosp. Clinico Univ. de Vallodolid; Comité Ético de Investigación Clínica Capio Hospital General de Catalunya; Comité Ético de Investigación Clínica de Galicia Secretaria Xeral Conselleria de Sanidade; and NRES Committee East of England-Cambridge South.
Financial support: This study was sponsored by Alcon Research, Ltd., Fort Worth, TX, USA.
Conflict of interest: C.B. is a consultant to Alcon and is a consultant to and has received research funding from Allergan, Santen, and Thea; M.L. is an occasional consultant to Alcon; A.O. is an Alcon employee; D.J.G., G.C.M.R., and I.J.V.d.M. have no conflicts to disclose.
Meeting presentation: Presented at the 121st Congress of the French Society of Ophthalmology; May 9-13, 2015, Paris, France; and at the European Society of Ophthalmology Congress; June 6-9, 2015, Vienna, Austria.

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Authors

Affiliations

  • 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

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