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NCT05966493 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Safety and Efficacy of NEXAGON® (Lufepirsen Ophthalmic Gel) in Subjects With PCED
A Phase 2 study of Persistent Corneal Epithelial Defect, sponsored by Glaukos Corporation.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 84
- Enrollment target
- 20
- Study locations
NCT05966493: Recruiting Phase 2 study of Persistent Corneal Epithelial Defect, sponsored by Glaukos Corporation.
NCT05966493 is a Phase 2 study of Persistent Corneal Epithelial Defect that is actively recruiting participants, run by Glaukos Corporation. The registered enrollment target is 84 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (37% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05966493, a Phase 2 study of Persistent Corneal Epithelial Defect, is actively recruiting participants, sponsored by Glaukos Corporation.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 84 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is to evaluate the safety and efficacy of NEXAGON® (lufepirsen ophthalmic gel) (NEXAGON) in subjects with persistent corneal epithelial defects (PCED). The objectives of the study are to evaluate the safety and efficacy of NEXAGON in this population.
Primary Outcome
The proportion of subjects achieving corneal re-epithelialization that is maintained for a minimum of 28 days, based on assessment of corneal fluorescein staining images of the PCED by a Central Reading Center (CRC).
Conditions Studied
Interventions
- DRUG Vehicle
- DRUG lufepirsen high dose
- DRUG lufepirsen low dose
Study Locations (20)
Florida
- Glaukos Investigative Site - Bradenton
- Glaukos Investigative Site - Fort Myers
- Glaukos Investigative Site - South Miami
California
- Glaukos Investigative Site - Petaluma
- Glaukos Investigative Site - Torrance
Colorado
- Glaukos Investigative Site - Colorado Springs
- Glaukos Investigative Site - Grand Junction
Missouri
- Glaukos Investigative Site - Kansas City
- Glaukos Investigative Site - Kansas City
Texas
- Glaukos Investigative Site - Houston
- Glaukos Investigative Site - San Antonio
Alabama
- Glaukos Investigative Site - Dothan
Georgia
- Glaukos Investigative Site - Atlanta
Indiana
- Glaukos Investigative Site - Carmel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2023-08-17 |
| Est. Completion | 2025-12 |
| Phase | Phase 2 |
What NCT05966493 shows while recruiting
NCT05966493 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (37% lower).
The record links to 1 condition, with Persistent Corneal Epithelial Defect appearing as the primary indexed condition, and to 3 interventions - of which Vehicle is the first listed.
NCT05966493 names 20 study sites across 14 states, led by Florida, California, Colorado.
Frequently Asked Questions
What is clinical trial NCT05966493 about?
NCT05966493 is a clinical study titled "A Study to Evaluate the Safety and Efficacy of NEXAGON® (Lufepirsen Ophthalmic Gel) in Subjects With PCED". This study is to evaluate the safety and efficacy of NEXAGON® (lufepirsen ophthalmic gel) (NEXAGON) in subjects with persistent corneal epithelial defects (PCED). The objectives of the study are to evaluate the safety and efficacy of NEXAGON in this population.
What is the current status of trial NCT05966493?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 84 participants. The study started on 2023-08-17. Estimated completion is 2025-12.
What conditions does trial NCT05966493 study?
This clinical trial studies the following conditions: Persistent Corneal Epithelial Defect.
What interventions are being tested in trial NCT05966493?
The interventions under investigation include: Vehicle (DRUG), lufepirsen high dose (DRUG), lufepirsen low dose (DRUG).
Who is sponsoring clinical trial NCT05966493?
This trial is sponsored by Glaukos Corporation, which has 33 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05966493 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05966493's enrollment target sits among peer trials
84 822nd of 2000 higher than 1,173 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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