A 4-Week, Phase II, Multicenter, Randomized, Double-Masked, Vehicle-Controlled, Parallel Group Study With 4 Weeks of Follow-Up to Evaluate Safety and Efficacy of a new formulation of Recombinant Human Nerve Growth Factor (rhNGF) Eye Drop Solution at two different Concentrations in patients with Dry Eye Disease (REDUCO study)

Dry Eye

The primary efficacy endpoint is the mean change from baseline to Week 8 in symptoms of dry eye assessed by SANDE Global Score [Time Frame: week 8 (V5)].

● Proportion of patients improving to Schirmer-I test without anesthesia ≥10mm/5min in the Study Eye [Time Frame: at week 4 (V4)], ● Mean change from baseline in Schirmer-I score without anesthesia in the Study Eye [Time frame: at week 4 (V4)], ● Mean change from baseline in total corneal fluorescein staining (NEI scale) in the Study Eye as assessed by the investigator [Time Frame: at week 4 (V4)], ● Mean change from baseline in Schirmer-I score without anesthesia in the Study Eye [Time frame: at week 8 (V5)], ● Proportion of patients improving to Schirmer-I test without anesthesia ≥10mm/5min in the Study Eye [Time Frame: at week 8 (V5)], ● Mean change from baseline in fluorescein tear break-up time (fTBUT)- in the Study Eye [Time Frame: at weeks 4 (V4) and 8 (V5)], ● Mean change from baseline in symptoms questionnaire (SANDE) scores for severity and frequency [Time Frame: at weeks 4 (V4) and 8 (V5)], ● Mean change from baseline in symptoms of dry eye assessed by SANDE Global Score [Time Frame: at week 4 (V4)], ● Mean change from baseline in total conjunctival lissamine green staining (NEI scale) in the Study eye as assessed by the investigator [Time Frame: at week 4 (V4)], ● Mean change from baseline in ocular pain assessed by the OPAS questionnaire’s pain scale [Time Frame: at weeks 4 (V4) and 8 (V5)], ● Mean change from baseline in best corrected distance visual acuity (BCDVA) [Time Frame: at weeks 4 (V4) and 8 (V5)], ● Mean change from baseline of QoL assessed by the OPAS questionnaire’s QoL score [Time Frame: at weeks 4 (V4) and 8 (V5)], ● Safety will be monitored by the incidence and frequency of Treatment-Emergent Adverse Events (TEAEs) assessed throughout the study including Run-In period., ● Mean change from baseline in corneal endothelial cell density in both eyes performed at sites that have a specular microscope [Time Frame: at week 8 (V5)], ● Change from baseline in the proportion of patients with vitritis, retinal or vitreal hemorrhages, increase in cup-to-disc ratio, retinal or posterior vitreal detachment, retinal tears, or maculopathy on dilated fundus exam (DFE) in both eyes [Time Frame: at week 8 (V5)], ● Mean change from baseline in bulbar conjunctival redness in both eyes (VBR 10 score) [Time Frame: at weeks 4 (V4) and 8 (V5)], ● Treatment discontinuation rate due to tolerability issues.

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