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NCT04498169 · ClinicalTrials.gov registry record · Phase 2
A Phase 2 Study Evaluating the Safety and Efficacy of Netarsudil Ophthalmic Solution in Patients With Corneal Edema Due to Fuchs Corneal Dystrophy
A Phase 2 study of Corneal Edema, sponsored by Aerie Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 12
- Study locations
NCT04498169: Completed Phase 2 study of Corneal Edema, sponsored by Aerie Pharmaceuticals.
NCT04498169 is a Phase 2 study of Corneal Edema that has completed, run by Aerie Pharmaceuticals. The registered enrollment target is 40 participants, below the 74-participant average among 4 other Corneal Edema trials with a reported enrollment target (46% lower). The trial reports 12 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04498169, a Phase 2 study of Corneal Edema, has completed, sponsored by Aerie Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 12
- Study locations
Study Summary
Two different dosing regimens (QD and BID) of netarsudil will be studied to evaluate their efficacy in reducing or resolving corneal edema in subjects with FCD.
Primary Outcome
Mean change from baseline in CCT by ultrasound pachymetry
Conditions Studied
Interventions
- DRUG Netarsudil Ophthalmic
Study Locations (12)
California
- Orange County Ophthalmology - Garden Grove
- Harvard Eye Associates - Laguna Hills
Minnesota
- Chu Vision Institute - Bloomington
- Minnesota Eye Care - Minnetonka
Kentucky
- Cincinnati Eye Institute - Edgewood
Massachusetts
- Advance Eye Associates - South Dartmouth
Missouri
- Ophthalmology Associates - St Louis
North Dakota
- Vance Thompson Vision - West Fargo
Ohio
- Comprehensive Eye Care - Westerville
South Dakota
- Vance Thompson Vision - Sioux Falls
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2020-09-17 |
| Est. Completion | 2021-08-11 |
| Phase | Phase 2 |
What the finished NCT04498169 record still lists
NCT04498169 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 74-participant average among 4 other Corneal Edema trials with a reported enrollment target (46% lower).
The record links to 1 condition, with Corneal Edema appearing as the primary indexed condition, and to 1 intervention - of which Netarsudil Ophthalmic is the first listed.
NCT04498169 lists 12 locations in 10 states (California, Minnesota, Kentucky).
Frequently Asked Questions
What is clinical trial NCT04498169 about?
NCT04498169 is a clinical study titled "A Phase 2 Study Evaluating the Safety and Efficacy of Netarsudil Ophthalmic Solution in Patients With Corneal Edema Due to Fuchs Corneal Dystrophy". Two different dosing regimens (QD and BID) of netarsudil will be studied to evaluate their efficacy in reducing or resolving corneal edema in subjects with FCD.
What is the current status of trial NCT04498169?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2020-09-17. Estimated completion is 2021-08-11.
What conditions does trial NCT04498169 study?
This clinical trial studies the following conditions: Corneal Edema.
What interventions are being tested in trial NCT04498169?
The interventions under investigation include: Netarsudil Ophthalmic (DRUG).
Who is sponsoring clinical trial NCT04498169?
This trial is sponsored by Aerie Pharmaceuticals, which has 32 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04498169 being conducted?
This trial has 12 study locations across California, Kentucky, Massachusetts, Minnesota, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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