Effectiveness of a New Active Tear Substitute Containing 0.2% Hyaluronic Acid and 0.001% Hydrocortisone on Signs and Symptoms of Dry Eye Disease by Means of Low- and High-Tech Assessments

Paolo Fogagnolo; Giuseppe Giannaccare; Rita Mencucci; Edoardo Villani; Vincenzo Orfeo; Pasquale Aragona; Italian Dry Eye Study Group

doi:10.1007/s40123-023-00833-7

Effectiveness of a New Active Tear Substitute Containing 0.2% Hyaluronic Acid and 0.001% Hydrocortisone on Signs and Symptoms of Dry Eye Disease by Means of Low- and High-Tech Assessments

Ophthalmol Ther. 2024 Jan;13(1):251-266. doi: 10.1007/s40123-023-00833-7. Epub 2023 Nov 10.

Authors

Paolo Fogagnolo¹, Giuseppe Giannaccare², Rita Mencucci³, Edoardo Villani⁴, Vincenzo Orfeo⁵, Pasquale Aragona⁶; Italian Dry Eye Study Group

Collaborators

Italian Dry Eye Study Group:
Valentino De Ruvo, Alfonso Strianese, Chiara Quisisana, Massimiliano Borselli, Costanza Rossi, Giovanna Carnovale Scalzo, Elisa Imelde Postorino, Claudia Azzaro, Stefano Mercuri, Flavia Lucarelli, Chiara De Vitto, Eleonora Ferioli, Luca Marelli, Pasquale Napolitano, Mario Cristian Giannì

Affiliations

¹ Health Sciences Department, Università degli Studi di Milano, Milan, Italy. [email protected].
² Department of Ophthalmology, University Magna Graecia of Catanzaro, Catanzaro, Italy.
³ Department of Neurosciences, Psychology, Drug Research, and Child Health, Eye Clinic, University of Florence, AOU Careggi, 50139, Florence, Italy.
⁴ Department of Clinical Science and Community Health, University of Milan, Eye Clinic San Giuseppe Hospital, IRCCS Multimedica, Milan, Italy.
⁵ Unità Operativa di Oculistica Clinica Mediterranea, Naples, Italy.
⁶ Department of Biomedical Sciences, Eye Clinic, University of Messina, Messina, Italy.

Abstract

Introduction: An innovative eye drops formulation containing 0.2% hyaluronic acid and a low concentration of hydrocortisone (0.001%; hereafter HALH) has been recently placed on the market (Idroflog^®, Alfa Intes, Italy) to manage the dysregulated parainflammation in patients with dry eye disease (DED). In the present paper, the effectiveness of HALH on the signs and symptoms of DED was retrospectively evaluated and compared with that one obtained using standard tear substitutes (STS) by means of low- and high-tech (Keratograph^®) assessments.

Methods: This was a multicenter retrospective study carried out between February and April 2023, involving adult patients with DED diagnosis owing to post-cataract surgery, meibomian gland dysfunction, allergy, or glaucoma medications. The primary aim was to compare the changes induced by different therapies on Keratograph^® parameters (noninvasive Keratograph tear breakup time [NIKBUT], tear meniscus height [TMH], eyelid meibography, conjunctival hyperemia, and conjunctivochalasis) or collected by traditional low-tech measures (tear breakup time [TBUT], Schirmer test, Efron score, and epithelial alterations) and the Ocular Surface Disease Index score.

Results: Data from 155 patients were analyzed. The effectiveness of HALH and STS was reported by both high- and low-tech measures. NIKBUT-first showed a significant improvement in the HALH group versus the STS one at 15 days (6.4 ± 3.6 vs 5.4 ± 3.7 s, p = 0.02), whereas this difference was latent with low-tech TBUT until 45 days (6.8 ± 2.6 vs 5.6 ± 2.3 s, p = 0.03). Patients with DED occurring after cataract surgery reported an enhanced activity of HALH versus STS, particularly for NIKBUT-first, TMH, Schirmer test, and hyperemia stage.

Conclusion: These findings highlighted the effectiveness of HALH in all DED subtypes, especially in patients with post-cataract surgery, as well as its superiority versus STS in terms of tear film stability improvement. We recommend longer observation (i.e., 3-6 months) to fully ascertain whether the early improvement detected by high-tech measures will be confirmed in subsequent time points even using low-tech tests.

Keywords: DED; Dry eye disease; Hydrocortisone; Inflammation; Lubricating eye drops; Tear film.