Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A 8 Weeks, Phase II, Single-centre, Randomized, Double-masked, Vehicle-controlled, Parallel Group Study With 4 Weeks of Follow-up to Evaluate Preliminary Efficacy and Safety of Recombinant Human Nerve
Brief Summary:
The proposed phase II study is a single-centre, randomized, double masked, parallel arm, vehicle-controlled trial, designed to evaluate the preliminary efficacy and safety of rhNGF eye drops at 20 µg/ml concentration administered six times daily for 8 weeks in patients who underwent cataract and corneal refractive surgery, both known to damage the corneal sensory nerve plexus.
After confirmation of inclusion and exclusion criteria all eligible patients will be randomized at 2:1 ratio to rhNGF or vehicle control treatment with 8 weeks of study treatments administration with 4 weeks Follow-up.