Randomised, controlled study of the efficacy and safety of a new eye-drop formulation for moderate to severe dry eye syndrome
Abstract
Purpose
The aim of this study was to compare the efficacy and safety in Dry Eye Disease (DED) of T2762, a new product containing an innovative bioprotective molecule trehalose (molecule finds in plants resistant to dissication with osmoprotectant properties) and hyaluronic acid, to Vismed®.
Methods
Phase III, randomized, active-controlled, Investigator-masked, multicentric study in France and Tunisia. 105 Adult patients (≥18 years) with moderate to severe DED were included and received one drop of either T2762 (N = 52) or Vismed® (N = 53) 3-6 times per day for 84 days. The primary efficacy variable was the Oxford grading score at Day 35. Ocular Surface Disease Index (OSDI), dry eye symptoms, Schirmer test, TBUT, conjunctival hyperaemia, and global performance were assessed as secondary efficacy criteria at baseline, Day 35 and Day 84. Safety assessments were standard.
Results
Non-inferiority of T2762 to Vismed® for Oxford grading score was demonstrated at Day 35. For secondary efficacy parameters, reductions in OSDI, dry eye symptoms and investigator/patient assessments of global performance were better for T2762. There were no clinically meaningful between-group differences for the other secondary criteria. Both treatments were well tolerated. Interestingly, there were fewer ocular symptoms upon instillation and fewer AEs with T2762.
Conclusions
T2762 is effective and safe, with better patient satisfaction than existing hyaluronate-only eye drops, and offers a therapeutic advancement in the treatment of moderate to severe DED.
