Abstract
Purpose :
The main scope of this meta-analysis is to compile information from existing studies about the efficacy of the tear substitute Thealoz® Duo (containing two active ingredients: trehalose and hyaluronic acid) in dry eye (DE) patients.
Methods :
The list of parameters to be analysed was decided at a preliminary stage via a feasibility analysis and includes the parameters most frequently encountered in bibliography, namely OSDI, Schirmer test and TBUT. Furthermore, based on the same feasibility analysis, the following timepoints were chosen for investigation of Thealoz® Duo (Laboratoires Thea, Clermont Ferrand-France) efficacy over time: week 1 (W1), month 1 (M1) and the time interval between month 2 and 4 (M2-M4) after intervention.
Given the inherent heterogeneity among studies mainly in terms of the study design and patient’s characteristics, the average changes from baseline were investigated. Overall, 7 studies were included. Pooled analysis was performed using the mean difference from each respective timepoint from baseline along with the corresponding standard errors, for each parameter/timepoint combination separately. For the analysis, fixed or random effects models were implemented, according to whether individual study results were homogeneous or heterogeneous (as denoted by I2 and chi-square test).
Results :
In terms of OSDI, although changes at W1 from baseline were non-significant, pooled results revealed a significant decrease at M1 from baseline (n=77 patients) of 18.8 (SE=4.7) units, and M2-4 from baseline (n=354) of 18.7 (SE=3.8) units, for the tear studies. Regarding Schirmer test, a significant increase was shown at M1 from baseline (n=77) of 1.5 (SE=0.5) units and M2-4 from baseline (n=252) of 1.7 (SE=0.7) units. For TBUT significant increases of 1.5 (SE=0.7) units were detected in the period M2-4 from baseline (n=311).
Conclusions :
This meta-analysis results confirmed a decrease in dry eye signs and symptoms after M1 and M2-4 months’ treatment with trehalose/hyaluronate tear substitute in DE patients. These results may be associated with the synergic action of both trehalose and hyaluronic acid in targeting different entries of the DE vicious loop.
This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.