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NCT03019627 · ClinicalTrials.gov registry record · Phase 2
An 8-week Study to Evaluate Safety and Efficacy of NGF Eye Drops Solution Versus Vehicle in Patients With Dry Eye
A Phase 2 study of Dry Eye, sponsored by Dompé Farmaceutici S.p.A.
- Completed
- Registry status
- Phase 2
- Development phase
- 150
- Enrollment target
- 1
- Study location
NCT03019627: Completed Phase 2 study of Dry Eye, sponsored by Dompé Farmaceutici S.p.A.
NCT03019627 is a Phase 2 study of Dry Eye that has completed, run by Dompé Farmaceutici S.p.A. The registered enrollment target is 150 participants, above the 92-participant average among 41 other Dry Eye trials with a reported enrollment target (63% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03019627, a Phase 2 study of Dry Eye, has completed, sponsored by Dompé Farmaceutici S.p.A.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 150 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Change from baseline with Last Observation Carried Forward (LOCF) imputation. LOCF is a method of imputing missing data in longitudinal studies and tests for difference in mean rates of change in controlled repeated measurements designs with dropouts. The SANDE score is calculated by taking the square root of the product of the frequency of symptoms score and the severity of symptoms score. The SANDE scale ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being th
Conditions Studied
Interventions
- OTHER Vehicle
- DRUG NGF
Study Locations (1)
Pennsylvania
- Penn Dry Eye and Ocular Surface Center, University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2017-01-20 |
| Est. Completion | 2017-08-31 |
| Phase | Phase 2 |
What the finished NCT03019627 record still lists
NCT03019627 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, above the 92-participant average among 41 other Dry Eye trials with a reported enrollment target (63% higher).
The record links to 1 condition, with Dry Eye appearing as the primary indexed condition, and to 2 interventions - of which Vehicle is the first listed.
NCT03019627 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03019627 about?
NCT03019627 is a clinical study titled "An 8-week Study to Evaluate Safety and Efficacy of NGF Eye Drops Solution Versus Vehicle in Patients With Dry Eye". 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...
What is the current status of trial NCT03019627?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 150 participants. The study started on 2017-01-20. Estimated completion is 2017-08-31.
What conditions does trial NCT03019627 study?
This clinical trial studies the following conditions: Dry Eye.
What interventions are being tested in trial NCT03019627?
The interventions under investigation include: Vehicle (OTHER), NGF (DRUG).
Who is sponsoring clinical trial NCT03019627?
This trial is sponsored by Dompé Farmaceutici S.p.A, which has 27 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03019627 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Dry Eye
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03019627's enrollment target sits among peer trials
150 7th of 41 higher than 35 of 41 other Dry Eye trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Dry Eye trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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