Efficacy of polyethylene glycol–propylene glycol-based lubricant eye drops in reducing squamous metaplasia in patients with dry eye disease
Authors Aguilar A, Berra M, Trédicce J, Berra A
Received 7 February 2018
Accepted for publication 7 April 2018
Published 12 July 2018 Volume 2018:12 Pages 1237—1243
Checked for plagiarism Yes
Review by Single-blind
Peer reviewers approved by Dr Colin Mak
Peer reviewer comments 2
Editor who approved publication: Dr Scott Fraser
Alejandro Aguila,1,2 Martin Berra,3 Jorge Trédicce,4 Alejandro Berra5
1Department of Ophthalmology, Medical Group Las Lomas, Buenos Aires, Argentina; 2Department of Ophthalmology, University of Salvador, Buenos Aires, Argentina; 3Department of Ophthalmology, Lagleyze Hospital, Buenos Aires, Argentina; 4Department of Ophthalmology, Santa Lucia Hospital, Buenos Aires, Argentina; 5Department of Pathology, University of Buenos Aires, Buenos Aires, Argentina
Purpose: Squamous metaplasia in dry eye disease (DED) manifesting as the loss of conjunctival goblet cells results in reduced mucin secretion and tear film instability. The objective of this study was to evaluate the efficacy of a polyethylene glycol–propylene glycol/hydroxypropyl-guar (PEG-PG/HP-guar) artificial tear formulation in reducing the squamous metaplasia in patients with DED using conjunctival impression cytology (CIC).
Methods: In this Phase IV, single-arm, open-label study, DED patients (aged ≥18 years) with a corneal staining sum score ≥3 and tear film break-up time (TFBUT) <7 s self-administered the PEG-PG/HP-guar artificial tears, 3 times a day for a period of 90 days. The primary end point was the change from baseline in goblet cell density (Nelson’s CIC grading score) over the treatment period. Other end points were change in the corneal and conjunctival staining scores, and TFBUT. Statistical evaluation was performed using a paired t-test.
Results: In total, 49 patients (n=98 eyes) completed the study. Compared with baseline, there was a significant reduction in the mean CIC scores (ie, improvement in goblet cell density) at Days 30, 60, and 90 (1.6±0.5 vs 1.2±0.5, 0.9±0.5, and 0.8±0.5; P<0.0001). At Day 90, 22% of eyes demonstrated squamous metaplasia Grade 0 (ie, normal epithelium). Similar improvements were observed in the corneal staining scores (5.7 vs 3.1, 1.1, and 0.5; P<0.0001), conjunctival staining scores (5.5 vs 3.6, 1.6, and 0.9; P<0.0001), and TFBUT (4.8 vs 5.8, 6.3, and 6.8 s; P<0.0001) at Days 30, 60, and 90, respectively.
Conclusion: In this study, treatment with PEG-PG/HP-guar artificial tears for 90 days decreased CIC score, reduced corneal and conjunctival staining, and increased TFBUT in patients with DED. These results suggest that PEG-PG/HP-guar artificial tears can improve the ocular surface health and reverse the changes induced by squamous metaplasia in DED.
Keywords: artificial tears, hydroxypropyl-guar, squamous metaplasia, dry eye disease
This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License. By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms.Download Article [PDF] View Full Text [HTML][Machine readable]