A Study to Evaluate the Safety and Efficacy of NEXAGON® (Lufepirsen Ophthalmic Gel) in Subjects With PCED
Condition(s) studied
Investigational drug(s) / intervention(s)
lufepirsen high dose: Lufepirsen is an unmodified connexin43 antisense oligonucleotide.
Vehicle: Matching vehicle without lufepirsen.
lufepirsen low dose: Lufepirsen is an unmodified connexin43 antisense oligonucleotide.
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.
Eligibility
Primary outcome measure(s)
- Achieve Corneal Re-epithelialization Including Durability (CRC) — End of Study: 28 Days after achieving re-epithelialization
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).
Trial sites (28)
| Facility | City | Region | Status |
|---|---|---|---|
| Glaukos Investigative Site | Dothan | Alabama | Recruiting |
| Glaukos Investigative Site | Petaluma | California | Recruiting |
| Glaukos Investigative Site | Torrance | California | Recruiting |
| Glaukos Investigative Site | Colorado Springs | Colorado | Recruiting |
| Glaukos Investigative Site | Grand Junction | Colorado | Recruiting |
| Glaukos Investigative Site | Bradenton | Florida | Recruiting |
| Glaukos Investigative Site | Fort Myers | Florida | Recruiting |
| Glaukos Investigative Site | South Miami | Florida | Recruiting |
| Glaukos Investigative Site | Atlanta | Georgia | Recruiting |
| Glaukos Investigative Site | Carmel | Indiana | Recruiting |
| Glaukos Investigative Site | Fraser | Michigan | Recruiting |
| Glaukos Investigative Site | Kansas City | Missouri | Recruiting |
| Glaukos Investigative Site | Kansas City | Missouri | Recruiting |
| Glaukos Investigative Site | Palisades Park | New Jersey | Recruiting |
| Glaukos Investigative Site | Shelby | North Carolina | Recruiting |
| Glaukos Investigative Site | Bala-Cynwyd | Pennsylvania | Recruiting |
| Glaukos Investigative Site | Nashville | Tennessee | Recruiting |
| Glaukos Investigative Site | Houston | Texas | Recruiting |
| Glaukos Investigative Site | San Antonio | Texas | Recruiting |
| Glaukos Investigative Site | Madison | Wisconsin | Recruiting |
| Glaukos Investigative Site | Milwaukee | Wisconsin | Recruiting |
| Glaukos Investigative Site | Mainz | Germany | Recruiting |
| Glaukos Investigative Site | München | Germany | Recruiting |
| Glaukos investigative Site | Messina | Italy | Recruiting |
| Glaukos Investigative Site | Barcelona | Spain | Recruiting |
| Glaukos Investigative Site | Madrid | Spain | Recruiting |
| Glaukos Investigative Site | Seville | Spain | Recruiting |
| Glaukos Investigative Site | Zaragoza | Spain | Recruiting |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05966493 on ClinicalTrials.gov ↗ ← All trials in Spain