At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A 4 Weeks, Phase II, Multicenter, Randomized, Double-masked, Vehicle-controlled, Parallel Group Study With 12 Weeks of Follow-up to Evaluate Safety and Efficacy of rhNGF Eye Drops Solution vs Vehicle in Moderate to Severe Dry Eye.
In Brief
A Phase 2 clinical trial evaluating rhNGF 20 μg/ml, rhNGF 20 μg/ml + vehicle, and 1 other intervention for Dry Eye Syndrome. Completed, enrolled 261 participants across 12 sites.
Detailed Summary
The objective of this study is to assess the efficacy and safety of rhNGF eye drops at 20 μg/ml concentration administered two or three times daily for 4 weeks in patients with moderate to severe dry eye.
Study Details
Timeline
Interventions
one drop of rhNGF 20 μg/ml will be instilled in both eyes three times daily (every 6-8 hours)
one drop of rhNGF 20 μg/ml will be instilled in both eyes two times daily plus one drop (40 μL) of vehicle will be instilled in both eyes once daily (every 6-8 hours). rhNGF will be instilled in the morning and in the evening while the vehicle will be instilled in the afternoon.
one drop of vehicle will be instilled in both eyes three times daily (every 6-8 hours)