Long-Term Activity and Safety of a Low-Dose Hydrocortisone Tear Substitute in Patients with Dry Eye Disease

Abstract

Purpose

A clinical trial was conducted to evaluate the activity of a new artificial tear containing hyaluronic acid (HA) and low-dose hydrocortisone to control dry-eye disease (DED) symptoms.

Methods

a randomized, controlled, double-masked study was carried out at the Ocular Surface and Dry Eye Center, “Luigi Sacco” University Hospital (Milan, Italy), between June 2020 and June 2021. The study involved patients with DED for at least 6 months. After an initial 7-day treatment with corticosteroid, the treatment with the new artificial tear (four-times a day for 6 months) was compared with a control HA solution.

Results

A total of 40 patients were considered. We observed a significant improvement in the frequency and intensity of DED symptoms in both groups. After corticosteroid discontinuation, the maintenance of the therapeutic advantage was observed only in the treatment group, which also showed a significant improvement of the tear film break-up time (p ≤ 0.05) and infiltrated macrophages (p < 0.05). A significant reduction in fluorescein and Lissamine staining (p < 0.05) was observed in the treatment group, suggesting damage reduction at both corneal and conjunctival levels. Intraocular pressure did not change at the end of the treatment period and was maintained within the normal range, sustaining the product’s safety.

Conclusions

Our findings support the prolonged use of the new eye drop with low-dose hydrocortisone, also in the DED initial stages, to prevent the degenerating towards a chronic condition (http://www.isrctn.com/ISRCTN16288419).

Keywords:

• Dry eye disease
• hydrocortisone
• hyaluronic acid
• para-inflammation
• ocular surface disease

Acknowledgments

Editorial and graphical assistance were provided by Simonetta Papa, PhD, Massimiliano Pianta, Valentina Attanasio and Aashni Shah (Polistudium SRL, Milan, Italy). This assistance was supported by Alfa Intes.

Ethical approval

The study was conducted within the protocol approved by the ethics committee of Milano Area 1 (register number 39408/2019).

Consent to participate

All the participants signed an informed consent form.

Consent for publication

Not required as this manuscript does not include details, images, or videos related to the participants.

Author contributions

MR contributed to writing the article, EV, LL, CL collected data from patients and impression cytology samples, PF provided insights for the projects, SB was responsible for the protocol. All Authors contributed to data collection and interpretation. All Authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

Disclosure statement

Maurizio Rolando and Stefano Barabino are consultants for Alfa Intes.

Data availability statement

The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

Additional information

Funding

The authors received no financial support for the research, authorship, and/or publication of this article.