Actively Recruiting

Phase 2
Age: 2Years +
All Genders
NCT05966493

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

On this page

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

Age: 2Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

Actively Recruiting

3

Glaukos Investigative Site

Torrance, California, United States, 90505

Actively Recruiting

4

Glaukos Investigative Site

Colorado Springs, Colorado, United States, 80924

Actively Recruiting

5

Glaukos Investigative Site

Grand Junction, Colorado, United States, 81501

Actively Recruiting

6

Glaukos Investigative Site

Bradenton, Florida, United States, 34209

Actively Recruiting

7

Glaukos Investigative Site

Fort Myers, Florida, United States, 33907

Actively Recruiting

8

Glaukos Investigative Site

South Miami, Florida, United States, 33143

Actively Recruiting

9

Glaukos Investigative Site

Atlanta, Georgia, United States, 30339

Actively Recruiting

10

Glaukos Investigative Site

Carmel, Indiana, United States, 46032

Actively Recruiting

11

Glaukos Investigative Site

Fraser, Michigan, United States, 48026

Actively Recruiting

12

Glaukos Investigative Site

Kansas City, Missouri, United States, 64133

Actively Recruiting

13

Glaukos Investigative Site

Kansas City, Missouri, United States, 64154

Actively Recruiting

14

Glaukos Investigative Site

Palisades Park, New Jersey, United States, 07650

Actively Recruiting

15

Glaukos Investigative Site

Shelby, North Carolina, United States, 28150

Actively Recruiting

16

Glaukos Investigative Site

Bala-Cynwyd, Pennsylvania, United States, 19004

Actively Recruiting

17

Glaukos Investigative Site

Nashville, Tennessee, United States, 37215

Actively Recruiting

18

Glaukos Investigative Site

Houston, Texas, United States, 77025

Actively Recruiting

19

Glaukos Investigative Site

San Antonio, Texas, United States, 78209

Actively Recruiting

20

Glaukos Investigative Site

Madison, Wisconsin, United States, 53705

Actively Recruiting

21

Glaukos Investigative Site

Milwaukee, Wisconsin, United States, 53226

Actively Recruiting

22

Glaukos Investigative Site

Mainz, Germany

Actively Recruiting

23

Glaukos Investigative Site

München, Germany

Actively Recruiting

24

Glaukos investigative Site

Messina, Italy

Actively Recruiting

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

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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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