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

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

Research output: Contribution to journalArticle

3 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)122-128
Number of pages7
JournalEuropean Journal of Ophthalmology
Volume27
Issue number2
DOIs
Publication statusPublished - Mar 1 2017

Fingerprint

Lubricants
Ophthalmic Solutions
Propylene Glycol
Oils
Lipids
Phospholipids
Tears
Confidence Intervals
Staining and Labeling
Therapeutics
Random Allocation
hydroxypropyl guar

Keywords

  • Hydroxypropyl guar
  • Ocular surface staining
  • Propylene glycol
  • Quality of life
  • Systane Balance
  • Tear film break-up time

ASJC Scopus subject areas

  • Medicine(all)
  • Ophthalmology

Cite this

Baudouin, C., Galarreta, D. J., Mrukwa-Kominek, E., Böhringer, D., Maurino, V., Guillon, M., ... Labetoulle, M. (2017). Clinical evaluation of an oil-based lubricant eyedrop in dry eye patients with lipid deficiency. European Journal of Ophthalmology, 27(2), 122-128. https://doi.org/10.5301/ejo.5000883

Clinical evaluation of an oil-based lubricant eyedrop in dry eye patients with lipid deficiency. / Baudouin, Christophe; Galarreta, David J.; Mrukwa-Kominek, Ewa; Böhringer, Daniel; Maurino, Vincenzo; Guillon, Michel; Rossi, Gemma C.M.; Van der Meulen, Ivanka J.; Ogundele, Abayomi; Labetoulle, Marc.

In: European Journal of Ophthalmology, Vol. 27, No. 2, 01.03.2017, p. 122-128.

Research output: Contribution to journalArticle

Baudouin, C, Galarreta, DJ, Mrukwa-Kominek, E, Böhringer, D, Maurino, V, Guillon, M, Rossi, GCM, Van der Meulen, IJ, Ogundele, A & Labetoulle, M 2017, 'Clinical evaluation of an oil-based lubricant eyedrop in dry eye patients with lipid deficiency', European Journal of Ophthalmology, vol. 27, no. 2, pp. 122-128. https://doi.org/10.5301/ejo.5000883
Baudouin C, Galarreta DJ, Mrukwa-Kominek E, Böhringer D, Maurino V, Guillon M et al. Clinical evaluation of an oil-based lubricant eyedrop in dry eye patients with lipid deficiency. European Journal of Ophthalmology. 2017 Mar 1;27(2):122-128. https://doi.org/10.5301/ejo.5000883
Baudouin, Christophe ; Galarreta, David J. ; Mrukwa-Kominek, Ewa ; Böhringer, Daniel ; Maurino, Vincenzo ; Guillon, Michel ; Rossi, Gemma C.M. ; Van der Meulen, Ivanka J. ; Ogundele, Abayomi ; Labetoulle, Marc. / Clinical evaluation of an oil-based lubricant eyedrop in dry eye patients with lipid deficiency. In: European Journal of Ophthalmology. 2017 ; Vol. 27, No. 2. pp. 122-128.
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