Comparison of the effect of a hyaluronate–trehalose solution to hyaluronate alone on Ocular Surface Disease Index in patients with moderate to severe dry eye disease

Abstract

Objective: To describe a post hoc analysis comparing the effect of a hyaluronic acid (HA)–trehalose solution to an established eyedrop solution containing HA alone using Ocular Surface Disease Index (OSDI) score <19 as a threshold for moderate to severe dry eye disease (DED).

Methods: A phase III, randomized, controlled, single-blind, multicenter study was conducted in France and Tunisia to evaluate the efficacy and safety of HA–trehalose (N = 52) and HA (N = 53) administered for 84 days. Eligible patients had moderate to severe DED with OSDI ≥18. Here the results of a post hoc analysis of the percentage of patients with OSDI <19 on Day 35 and Day 84 are reported.

Results: Significantly more patients had OSDI <19 at Day 84 in the HA–trehalose group than in the HA group (78.8% versus 58.5%; p = .025). At Day 35, more patients had OSDI <19 in the HA–trehalose group than in the HA group, but this difference was not statistically significant. Furthermore, approximately twice as many patients in the HA group (41.5%) still had OSDI 19–100 at Day 84 compared to the HA–trehalose group (21.2%).

Conclusions: This data supports the addition of trehalose to HA-containing eyedrop solutions to provide better symptomatic relief from moderate to severe DED, based on an OSDI score of <19 after 84 days of treatment.

Keywords:

• Bioprotection
• dry eye
• hyaluronic acid
• ocular surface disease index
• trehalose

Transparency

Declaration of funding

This study was supported by Laboratoires Théa, Clermont-Ferrand, France.

Declaration of financial/other relationships

S.D. has disclosed that he has acted as a paid consultant for Alcon-Novartis, Allergan, Bausch & Lomb, Horus, Santen, and Laboratoires Théa. D.B.-G. and F.C. have disclosed that they have acted as paid consultants for Alcon-Novartis, Allergan, Horus, Santen and Laboratoires Théa.

A CMRO peer reviewer on this manuscript has declared receiving research funding from Laboratoires Théa in the past. The other CMRO peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Acknowledgements

The study personnel and patients are acknowledged for their participation. The authors would also like to thank Dr Andrew Lane (Lane Medical Writing) who provided professional medical writing assistance, funded by Laboratoires Théa, in the preparation and development of this manuscript in accordance with the European Medical Writers Association guidelines and Good Publication Practice.

Notes

^aThealoz Duo and Théalose are registered trade names of Laboratoires Théa, France.

^bVismed is a registered trade name of Horus Pharma, France.

^cHydrabak is a registered trade name of Laboratoires Théa, Clermont Ferrand, France.