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A Randomized, Double-Masked, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of NEXAGON4 (Lufepirsen Ophthalmic Gel) in Persistent Corneal Epithelial Defects
Led by Glaukos Corporation · Updated on 2025-07-24
84
Participants Needed
28
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of NEXAGON4 (lufepirsen ophthalmic gel) in people with persistent corneal epithelial defects (PCED), a condition where the corneal surface does not heal properly. This randomized, double-masked, vehicle-controlled study aims to understand how well NEXAGON works in treating PCED and its durability after treatment. This Phase 2 trial is sponsored by Glaukos Corporation and is conducted at multiple centers. Participants will be randomly assigned to receive one of three treatments applied topically to the eye once a week for 4 to 8 weeks: a high dose of lufepirsen, a low dose of lufepirsen (available only at EU sites), or a vehicle gel without the active drug. After the treatment period, a 4-week follow-up will monitor the condition. If the corneal defect does not heal or the healing is not maintained for 28 days, participants may enter an open-label treatment phase with NEXAGON for an additional 8 weeks. During the study, participants will undergo screening to confirm eligibility, receive weekly treatment applications, and be monitored for safety and healing progress. Researchers will assess corneal re-epithelialization and its durability as the main outcome. The total study participation includes the screening, up to 8 weeks of treatment, 4 weeks of follow-up, and possibly an 8-week open-label extension. Safety, efficacy, and healing durability will be closely observed throughout these periods.
CONDITIONS
Brief Title
A Study to Evaluate the Safety and Efficacy of NEXAGON® (Lufepirsen Ophthalmic Gel) in Subjects With PCED
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have a persistent corneal epithelial defect (PCED) lasting at least 2 weeks that has not improved with one or more standard non-surgical treatments
- No clinical improvement in PCED within 2 weeks before randomization despite treatment
- Provide written informed consent or assent
- If female with childbearing potential, must be 1 year postmenopausal, surgically sterilized, or have a negative urine pregnancy test
You will not qualify if you...
- Have an active ocular infection needing treatment
- Have a corneal surface defect caused by unresolved or untreated infection (bacterial, viral, fungal, or protozoal)
- Have corneal ulceration, melting involving the posterior third of the stroma, or perforation in either eye
- Have clinically relevant or active blepharitis or meibomian gland disease in the study eye
- Have had ocular surgery or procedures not meeting the required washout period
- Have other ocular diseases requiring topical medication in the affected eye
- Have any ocular or systemic condition interfering with study safety, efficacy, or result interpretation
- Have known allergy to study drugs or procedural medications
- Participated in another interventional drug or device trial within 28 days before Day 1
- Use medications prohibited by the study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - Up to 8 weeks
Participants receive topical application of NEXAGON (lufepirsen ophthalmic gel) or vehicle once a week for a minimum of 4 weeks and up to 8 weeks to treat persistent corneal epithelial defects.
Weekly visits for up to 8 weeks
Duration - 4 weeks
Participants are followed for 4 weeks to assess the durability of corneal re-epithelialization after treatment completion.
Visits during the 4-week follow-up period
Duration - Up to 8 weeks
Participants whose corneal defect has not healed or who lost re-epithelialization durability after initial treatment may enter an open-label treatment phase with NEXAGON for an additional 8 weeks.
Weekly visits for up to 8 weeks
Trial Site Locations
Total: 28 locations
1
Glaukos Investigative Site
Dothan, Alabama, United States, 36301
Actively Recruiting
2
Glaukos Investigative Site
Petaluma, California, United States, 94954
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3
Glaukos Investigative Site
Torrance, California, United States, 90505
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4
Glaukos Investigative Site
Colorado Springs, Colorado, United States, 80924
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5
Glaukos Investigative Site
Grand Junction, Colorado, United States, 81501
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6
Glaukos Investigative Site
Bradenton, Florida, United States, 34209
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7
Glaukos Investigative Site
Fort Myers, Florida, United States, 33907
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8
Glaukos Investigative Site
South Miami, Florida, United States, 33143
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9
Glaukos Investigative Site
Atlanta, Georgia, United States, 30339
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10
Glaukos Investigative Site
Carmel, Indiana, United States, 46032
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11
Glaukos Investigative Site
Fraser, Michigan, United States, 48026
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12
Glaukos Investigative Site
Kansas City, Missouri, United States, 64133
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13
Glaukos Investigative Site
Kansas City, Missouri, United States, 64154
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14
Glaukos Investigative Site
Palisades Park, New Jersey, United States, 07650
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15
Glaukos Investigative Site
Shelby, North Carolina, United States, 28150
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16
Glaukos Investigative Site
Bala-Cynwyd, Pennsylvania, United States, 19004
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17
Glaukos Investigative Site
Nashville, Tennessee, United States, 37215
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18
Glaukos Investigative Site
Houston, Texas, United States, 77025
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19
Glaukos Investigative Site
San Antonio, Texas, United States, 78209
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20
Glaukos Investigative Site
Madison, Wisconsin, United States, 53705
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21
Glaukos Investigative Site
Milwaukee, Wisconsin, United States, 53226
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22
Glaukos Investigative Site
Mainz, Germany
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23
Glaukos Investigative Site
München, Germany
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24
Glaukos investigative Site
Messina, Italy
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25
Glaukos Investigative Site
Barcelona, Spain
Actively Recruiting
26
Glaukos Investigative Site
Madrid, Spain
Actively Recruiting
27
Glaukos Investigative Site
Seville, Spain
Actively Recruiting
28
Glaukos Investigative Site
Zaragoza, Spain
Actively Recruiting
Research Team
S
Study Director
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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