Clinical Efficacy, Tolerability and Safety of a New Multiple-Action Eyedrop in Subjects with Moderate to Severe Dry Eye

Introduction

Dry eye disease (DED) represents one of the most common eye disorders, with a reported prevalence rate ranging from 5 to 50 percent and peaking after the fifth decade of life. It has been identified as a disorder of the Lacrimal Functional Unit (LFU), an integrated system including lacrimal glands, ocular surface, eyelids, and sensory and motor nerves.

Resulting in significant morbidity, DED has a significant impact on patients’ visual function and quality of life. DED can present clinically with mild to severe ocular discomfort associated with signs and symptoms of varying intensity and visual acuity impairment.

In this prospective observational cohort study, 41 subjects with moderate to severe dry eye were enrolled and divided into two groups. Group 1 was treated with TriMix® and group 2 was treated with 3% Trehalose four times daily for 2 months. All subjects were evaluated at baseline (V0) and at day 60 ± 3 (V1). Assessment included at each follow-up measurement of best corrected visual acuity (BCVA), assessment of symptom frequency and intensity by questionnaire (SANDE), osmolarity, fluorescein tear film break-up time (TBUT), and corneal and conjunctival staining with fluorescein; assessment of the presence/absence of erythema and edema of the eyelids, conjunctival chemosis, and hyperemia was also performed.

Improvement of evaluation parameters

Trimix® achieved better results, with further significant improvement on symptom frequency, osmolarity.

Further statistical analysis showed a significantly greater amount of TBUT increase in patients treated with Trimix® compared with the group treated with 3% Trehalose alone.