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NCT04944290 · ClinicalTrials.gov registry record · Phase 3
To Compare the Efficacy and Safety of Perrigo's Product to an FDA Approved Product for the Treatment of Glaucoma or Ocular Hypertension in Both Eyes
A Phase 3 study, sponsored by Padagis.
- Completed
- Registry status
- Phase 3
- Development phase
- 447
- Enrollment target
NCT04944290: Completed Phase 3 study, sponsored by Padagis.
NCT04944290 is a Phase 3 study that has completed, run by Padagis. The registered enrollment target is 447 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04944290, a Phase 3 study, has completed, sponsored by Padagis.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 447 participants
- Enrollment target
Study Summary
To compare the efficacy and safety of Perrigo's product to an FDA approved product in the treatment of Primary Open Angle Glaucoma or Ocular Hypertension in Both Eyes.
Primary Outcome
mean change in intra-ocular pressure of both eyes between the two treatment groups at four time points: at approximately 8:00 a.m. (hour 0; before the morning drop) and approximately 10:00 a.m. (hour 2) on Day 14 (Week 2) and Day 42 (Week 6) visits. Mean change from baseline to Day X Hour Y for each subject was derived as the average of (Day X Hour Y - Day 0 Hour Y) from the left and right eyes, where X = 14, 42. and Y = 0, 2. A negative value indicates an improvement
Interventions
- DRUG Brinzolamide/brimonidine ophthalmic suspension
- DRUG Simbrinza 0.2%/1% Ophthalmic Suspension
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 447 participants |
| Start Date | 2021-05-28 |
| Est. Completion | 2022-06-21 |
| Phase | Phase 3 |
What the finished NCT04944290 record still lists
NCT04944290 is an interventional study that assigns participants to a tested intervention. The registered 447 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 (42% lower).
The record links to 0 conditions, and to 2 interventions - of which Brinzolamide/brimonidine ophthalmic suspension is the first listed.
NCT04944290 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04944290 about?
NCT04944290 is a clinical study titled "To Compare the Efficacy and Safety of Perrigo's Product to an FDA Approved Product for the Treatment of Glaucoma or Ocular Hypertension in Both Eyes". To compare the efficacy and safety of Perrigo's product to an FDA approved product in the treatment of Primary Open Angle Glaucoma or Ocular Hypertension in Both Eyes.
What is the current status of trial NCT04944290?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 447 participants. The study started on 2021-05-28. Estimated completion is 2022-06-21.
What interventions are being tested in trial NCT04944290?
The interventions under investigation include: Brinzolamide/brimonidine ophthalmic suspension (DRUG), Simbrinza 0.2%/1% Ophthalmic Suspension (DRUG).
Who is sponsoring clinical trial NCT04944290?
This trial is sponsored by Padagis, which has 17 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04944290's enrollment target sits among peer trials
447 864th of 2000 higher than 1,137 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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