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NCT03982368 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate Safety and Efficacy of rhNGF Eye Solution vs Vehicle in Patients With Moderate to Severe Dry Eye
A Phase 2 study, sponsored by Dompé Farmaceutici S.p.A.
- Completed
- Registry status
- Phase 2
- Development phase
- 261
- Enrollment target
NCT03982368: Completed Phase 2 study, sponsored by Dompé Farmaceutici S.p.A.
NCT03982368 is a Phase 2 study that has completed, run by Dompé Farmaceutici S.p.A. The registered enrollment target is 261 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03982368, a Phase 2 study, has completed, sponsored by Dompé Farmaceutici S.p.A.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 261 participants
- Enrollment target
Study 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.
Primary Outcome
The Schirmer test is used in ophthalmic examination to measure tear production for the diagnosis of conditions such as keratoconjunctivitis sicca and dry eye. Without previously instilling anesthetic drops, the Schirmer strip is inserted into the lower conjunctival sac at the junction of the lateral and middle thirds, avoiding touching the cornea, and the length of wetting strips in millimeters is recorded after 5 minutes. The patients will be instructed to close their eyes gently. After 5 min
Interventions
- OTHER Vehicle
- DRUG rhNGF 20 μg/ml
- DRUG rhNGF 20 μg/ml + vehicle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 261 participants |
| Start Date | 2019-06-10 |
| Est. Completion | 2020-07-15 |
| Phase | Phase 2 |
What the finished NCT03982368 record still lists
NCT03982368 is an interventional study that assigns participants to a tested intervention. The registered 261 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% higher).
The record links to 0 conditions, and to 3 interventions - of which Vehicle is the first listed.
NCT03982368 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03982368 about?
NCT03982368 is a clinical study titled "A Study to Evaluate Safety and Efficacy of rhNGF Eye Solution vs Vehicle in Patients With Moderate to Severe Dry Eye". 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.
What is the current status of trial NCT03982368?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 261 participants. The study started on 2019-06-10. Estimated completion is 2020-07-15.
What interventions are being tested in trial NCT03982368?
The interventions under investigation include: Vehicle (OTHER), rhNGF 20 μg/ml (DRUG), rhNGF 20 μg/ml + vehicle (DRUG).
Who is sponsoring clinical trial NCT03982368?
This trial is sponsored by Dompé Farmaceutici S.p.A, which has 27 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03982368's enrollment target sits among peer trials
261 210th of 2000 higher than 1,791 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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