At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years
- ✓Diagnosed dry eye (any type) at least 3 months before enrollment
- ✓Corneal/conjunctival staining with NEI grading >3
- ✓SANDE questionnaire score ≥30
- ✕Best corrected distance visual acuity <0.1 decimal units in either eye
- ✕Active ocular infection in either eye
- ✕Intraocular inflammation (Tyndall score >0)
- ✕Active or recent malignancy or current chemo/radiotherapy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An 8-week, Phase II, Single-center, Randomized, Double-masked, Vehicle-controlled, Parallel-group Study With 4 Weeks of Follow-up to Evaluate Safety and Efficacy of rhNGF Eye Drops Solution vs Vehicle in Patients With Dry Eye
In Brief
A Phase 2 clinical trial evaluating NGF and Vehicle for Dry Eye. Completed, enrolled 150 participants across 1 site.
Detailed Summary
The primary objective of this study was to assess the efficacy and safety of rhNGF when administered as eye drops to patients with dry eye The secondary objectives of this study were: * To assess change from baseline in Symptom Assessment In Dry Eye (SANDE) scores (without imputation), corneal and conjunctival staining according to National Eye Institute (NEI) scale, and in Tear Film Break-up Time (TFBUT) and Schirmer test I, following 4 and 8 weeks of treatment. * To assess change in levels of inflammatory biomarker matrix metallopeptidase 9 (MMP-9) in tears following 8 weeks of treatment. * To assess the incidence and frequency of treatment-emergent adverse events (TEAEs) following 8 weeks of treatment.
Study Details
Timeline
Interventions
Eye Drop 20 μg/mL
Vehicle Eye Drop