The objective is to demonstrate the non-inferiority of T2769 compared to Hylo-Forte® in terms of the change from baseline (D1) in total ocular surface staining score assessed on Oxford 0-15 scale, in the study eye at the D36 visit. The investigation is defined as a post-market stage. The clinical investigation design is confirmatory.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
74
Daily dose regimen: 1 drop in each eye, from 3 to 6 times daily.
Daily dose regimen: 1 drop in each eye, from 3 to 6 times daily.
OFTEX, s.r.o.
Prague, Czechia
Axon Clinical, s.r.o.
Prague, Czechia
Ganglion Medical Center
Pécs, Baranya, Hungary
Ermellek Egeszsegcentrum
Létavértes, Hb, Hungary
To Demonstrate the Non-inferiority of T2769 Compared to Hylo-Forte® in Terms of Total Ocular Surface Staining (Oxford Score).
The primary endpoint is the change from baseline (Day 1) in total ocular surface staining grade according to Oxford Scale 0-15 grading scheme at D36 in the study eye. Minimum value is 0 (better case) and maximum value is 15 (worse case)
Time frame: Oxford 0-15 grading scheme: is assessed at Day 1, Day 15 and Day 36
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