Abstract
Purpose :
Topically administered lubricants are fundamental for treating dry eye syndrome (DES). In this study, the protective mechanism conferred by the Thealoz® Duo eye drops was investigated in dry eye patients by longitudinal clinical examination and, subsequently, the tear proteome changes were characterized employing the mass spectrometry-based proteomics approach.
Methods :
A total of 58 participants underwent thorough DES diagnostic steps, namely the ocular surface disease index (OSDI) and, were divided into dry eye (DRY, N=35) and healthy (CTRL, N=23). Only participants in the DRY were subjected to administration of the Thealoz® Duo (hyaluronic acid 0.15% and trehalose 3%). All participants in both groups were scheduled for clinical investigation before the application (day 0, T1) of the Thealoz® Duo and after day 28 ± 4 (T2) and day 56 ± 4 (T3). Descriptive statistical analysis of all the clinical attributes of the participants were investigated. Next, 174 individual tear samples from both groups at three time-points were subjected to proteomics and in-silico bioinformatics analyses.
Results :
Application of Thealoz® Duo significantly improved the OSDI score in DRY at T2 vs. T1 (p=4.1E-3) and T3 vs. T1 (p=2.0E-5) as well as many visual analogue scale parameters. Proteomics analysis resulted in identification of 649 tear proteins (FDR<1%) and 144 were found to be significantly (p<0.05) differently abundant between the designated groups. Bioinformatics analysis revealed that in DRY vs. CTRL at T2 due to the usage of the Thealoz® Duo resulted in heightened molecular processes involved in glycolysis (p=2.3E-5), cellular homeostasis (p=2.4E-3), acute phase response (p=4.9E-3), actin cytoskeleton signaling (p=8.5E-3) and inhibition of apoptosis (p=4.1E-4). The hallmark of this study was that the activated inflammatory process in DRY vs. CTRL at T1 (p=9.7E-4) and T2 (p=8.7E-4) was inhibited at T3 of Thealoz® Duo use.
Conclusions :
In summary, this clinical investigation ascertained that the continual application of Thealoz® Duo significantly improved vision-related functions in DES patients. Notably, for the first time, the proteomics analysis unraveled novel mechanistic changes and expression of specific markers attributed to the efficacy of Thealoz® Duo in breaking the vicious cycle of inflammation and promoting the restoration of homeostasis on the ocular surface of DES patients.
This abstract was presented at the 2022 ARVO Annual Meeting, held in Denver, CO, May 1-4, 2022, and virtually.