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A Study to Evaluate the Safety and Efficacy of NEXAGON® (Lufepirsen Ophthalmic Gel) in Subjects With PCED
Led by Glaukos Corporation · Updated on 2025-07-24
84
Participants Needed
28
Research Sites
119 weeks
Total Duration
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AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 lasting at least 2 weeks that has not improved with one or more standard non-surgical treatments
- Show no clinical improvement of the defect in the 2 weeks before randomization despite treatment
- Provide written informed consent or assent
- If of childbearing potential, 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 defect due to unresolved or untreated infectious causes (bacterial, viral, fungal, protozoal)
- Have corneal ulceration or 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 any other eye disease requiring topical medication in the affected eye
- Have any ocular or systemic condition that could affect safety, efficacy, or study results
- Have known allergy to study medications or procedural agents like NEXAGON or fluorescein
- Participated in another interventional drug or device trial within 28 days before starting this study
- Use medications prohibited by the study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 28 locations
1
Glaukos Investigative Site
Dothan, Alabama, United States, 36301
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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
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26
Glaukos Investigative Site
Madrid, Spain
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27
Glaukos Investigative Site
Seville, Spain
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28
Glaukos Investigative Site
Zaragoza, Spain
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Research Team
S
Study Director
CONTACT
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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