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NCT04445519 · ClinicalTrials.gov registry record · Phase 3
Phase 3 Trial of NCX 470 vs. Latanoprost in Subjects With Open-Angle Glaucoma or Ocular Hypertension
A Phase 3 study, sponsored by Nicox Ophthalmics.
- Completed
- Registry status
- Phase 3
- Development phase
- 691
- Enrollment target
NCT04445519: Completed Phase 3 study, sponsored by Nicox Ophthalmics.
NCT04445519 is a Phase 3 study that has completed, run by Nicox Ophthalmics. The registered enrollment target is 691 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (10% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04445519, a Phase 3 study, has completed, sponsored by Nicox Ophthalmics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 691 participants
- Enrollment target
Study Summary
The objective of this clinical study is to evaluate the safety and efficacy of NCX 470 Ophthalmic Solution in lowering intraocular pressure (IOP) in patients with ocular hypertension or open-angle glaucoma. In the adaptive dose selection phase of the trial, subjects will be randomized in a 1:1:1 ratio to one of two doses of NCX 470 (0.065% or 0.1%) or to latanoprost 0.005%. Following the selection of one dose of NCX 470, subjects will be randomized in a 1:1 ratio to the chosen dose of NCX 470 or to latanoprost 0.005%.
Primary Outcome
The analysis performed as part of the Adaptive Dose Phase of the study was to evaluate the efficacy and safety of both concentrations of NCX 470 compared to Latanoprost. The primary endpoint for the interim analysis was mean diurnal IOP. Subsequent to the interim analysis at Week 2, the NCX 470 0.065% arm was discontinued and the primary analysis only included NCX 470 0.1% vs Latanoprost. The primary efficacy outcome results are reported for the NCX 470 0.1% and Latanoprost 0.005% treatment grou
Interventions
- DRUG NCX 470 0.065% (initial phase of trial)
- DRUG Latanoprost 0.005% (initial phase of trial)
- DRUG NCX 470 0.1% (initial phase of trial)
- DRUG NCX 470 0.1% (remainder of trial)
- DRUG Latanoprost 0.005% (remainder of trial)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 691 participants |
| Start Date | 2020-06-01 |
| Est. Completion | 2022-09-16 |
| Phase | Phase 3 |
What the finished NCT04445519 record still lists
NCT04445519 is an interventional study that assigns participants to a tested intervention. The registered 691 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (10% lower).
The record links to 0 conditions, and to 5 interventions - of which NCX 470 0.065% (initial phase of trial) is the first listed.
NCT04445519 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04445519 about?
NCT04445519 is a clinical study titled "Phase 3 Trial of NCX 470 vs. Latanoprost in Subjects With Open-Angle Glaucoma or Ocular Hypertension". The objective of this clinical study is to evaluate the safety and efficacy of NCX 470 Ophthalmic Solution in lowering intraocular pressure (IOP) in patients with ocular hypertension or open-angle glaucoma. In the adaptive dose selection phase of the trial, subjects will be randomized in a 1:1:1 rat...
What is the current status of trial NCT04445519?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 691 participants. The study started on 2020-06-01. Estimated completion is 2022-09-16.
What interventions are being tested in trial NCT04445519?
The interventions under investigation include: NCX 470 0.065% (initial phase of trial) (DRUG), Latanoprost 0.005% (initial phase of trial) (DRUG), NCX 470 0.1% (initial phase of trial) (DRUG), NCX 470 0.1% (remainder of trial) (DRUG), Latanoprost 0.005% (remainder of trial) (DRUG).
Who is sponsoring clinical trial NCT04445519?
This trial is sponsored by Nicox Ophthalmics, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04445519's enrollment target sits among peer trials
691 524th of 2000 higher than 1,477 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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