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NCT02855450 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate Safety and Efficacy of rhNGF Eye Drops Solution Versus Vehicle in Patients With Glaucoma
A Phase 1 study of Glaucoma, sponsored by Dompé Farmaceutici S.p.A.
- Completed
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT02855450 is a Phase 1 study of Glaucoma that has completed, run by Dompé Farmaceutici S.p.A. The registered enrollment target is 60 participants, below the 910-participant average among 92 other Glaucoma trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02855450, a Phase 1 study of Glaucoma, has completed, sponsored by Dompé Farmaceutici S.p.A.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary objective of the study is to assess the safety and tolerability of a 180μg/ml TID dose regimen of recombinant human nerve growth factor (rhNGF) eye drop solution administered over 8 weeks versus a vehicle control in patients with progressive primary open-angle glaucoma despite IOP control. The secondary objectives are to measure the changes in BCDVA, visual field, ERG and structural changes in ganglion cell layer and nerve fiber layer thickness measured by optical coherence tomography. The secondary outcomes will be examined at 1, 4 and 8 weeks of therapy, and at 4 and 24 weeks after cessation of therapy (Week 12 visit and Week 32 visit), and will include functional assessments to investigate evidence of a persistent biological effect after discontinuation of the study treatment.
Conditions Studied
Interventions
- DRUG Vehicle
- DRUG rhNGF
Study Locations (1)
California
- Byers Eye Institute at Stanford University - Palo Alto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2016-12 |
| Est. Completion | 2018-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02855450
The ClinicalTrials.gov registry entry for NCT02855450 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 910-participant average among 92 other Glaucoma trials with a reported enrollment target (93% lower). The listed sponsor is Dompé Farmaceutici S.p.A, which has 27 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Glaucoma appearing as the primary indexed condition, and to 2 interventions - of which Vehicle is the first listed.
NCT02855450 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT02855450 about?
NCT02855450 is a clinical study titled "Study to Evaluate Safety and Efficacy of rhNGF Eye Drops Solution Versus Vehicle in Patients With Glaucoma". The primary objective of the study is to assess the safety and tolerability of a 180μg/ml TID dose regimen of recombinant human nerve growth factor (rhNGF) eye drop solution administered over 8 weeks versus a vehicle control in patients with progressive primary open-angle glaucoma despite IOP contro...
What is the current status of trial NCT02855450?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2016-12. Estimated completion is 2018-05.
What conditions does trial NCT02855450 study?
This clinical trial studies the following conditions: Glaucoma.
What interventions are being tested in trial NCT02855450?
The interventions under investigation include: Vehicle (DRUG), rhNGF (DRUG).
Who is sponsoring clinical trial NCT02855450?
This trial is sponsored by Dompé Farmaceutici S.p.A, which has 27 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02855450 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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