A Study to Evaluate the Safety and Efficacy of NEXAGON® (Lufepirsen Ophthalmic Gel) in Subjects With PCED

Part of paid clinical trials in Dothan, Alabama.

Sponsor
Glaukos Corporation
Study ID
NCT05966493
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Persistent Corneal Epithelial Defect

Eligibility Criteria

Sex
ALL
Age
2 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • lufepirsen high dose — DRUG
    Lufepirsen is an unmodified connexin43 antisense oligonucleotide.
  • Vehicle — DRUG
    Matching vehicle without lufepirsen.
  • lufepirsen low dose — DRUG
    Lufepirsen is an unmodified connexin43 antisense oligonucleotide.

Study Details

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.

Key Dates

Start date
Aug 17, 2023
Status verified
Jul 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
84 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: NEXAGON® (lufepirsen ophthalmic gel) High Dose Concentration
    Lufepirsen (High dose concentration) applied topically to the eye once a week for a minimum of 4 weeks to a maximum of 8 weeks.
  • Placebo Comparator: NEXAGON Vehicle (ophthalmic gel)
    Vehicle applied topically to the eye once a week for a minimum of 4 weeks to a maximum of 8 weeks.
  • Experimental: NEXAGON® (lufepirsen ophthalmic gel) Low Dose Concentration (EU sites only)
    Lufepirsen (Low dose concentration) applied topically to the eye once a week for a minimum of 4 weeks to a maximum of 8 weeks. (EU sites only).

Primary Outcome Measure

Achieve Corneal Re-epithelialization Including Durability (CRC) [ Time Frame: End of Study: 28 Days after achieving re-epithelialization ]

Central Contacts

Locations (21)

FacilityCityStateZIPSite coordinators
Glaukos Investigative SiteDothanAlabama36301
Study Coordinator
949-739-8749
Glaukos Investigative SitePetalumaCalifornia94954
Study Coordinator
949-739-8749
Glaukos Investigative SiteTorranceCalifornia90505
Study Coordinator
949-739-8749
Glaukos Investigative SiteColorado SpringsColorado80924
Study Coordinator
949-739-8749
Glaukos Investigative SiteGrand JunctionColorado81501
Study Coordinator
949-739-8749
Glaukos Investigative SiteBradentonFlorida34209
Study Coordinator
949-739-8749
Glaukos Investigative SiteFort MyersFlorida33907
Study Coordinator
949-739-8749
Glaukos Investigative SiteSouth MiamiFlorida33143
Study Coordinator
949-739-8749
Glaukos Investigative SiteAtlantaGeorgia30339
Study Coordinator
949-739-8749
Glaukos Investigative SiteCarmelIndiana46032
Study Coordinator
949-739-8749
Glaukos Investigative SiteFraserMichigan48026
Study Coordinator
949-739-8749
Glaukos Investigative SiteKansas CityMissouri64133
Study Coordinator
949-739-8749
Glaukos Investigative SiteKansas CityMissouri64154
Study Coordinator
949-739-8749
Glaukos Investigative SitePalisades ParkNew Jersey07650
Study Coordinator
949-739-8749
Glaukos Investigative SiteShelbyNorth Carolina28150
Study Coordinator
949-739-8749
Glaukos Investigative SiteBala-CynwydPennsylvania19004
Study Coordinator
949-739-8749
Glaukos Investigative SiteNashvilleTennessee37215
Study Coordinator
949-739-8749
Glaukos Investigative SiteHoustonTexas77025
Study Coordinator
949-739-8749
Glaukos Investigative SiteSan AntonioTexas78209
Study Coordinator
949-739-8749
Glaukos Investigative SiteMadisonWisconsin53705
Study Coordinator
949-739-8749
Glaukos Investigative SiteMilwaukeeWisconsin53226
Study Coordinator
949-739-8749

Find similar trials in Dothan, AL

By research site
Glaukos Investigative Site· Dothan, ALGlaukos Investigative Site· Petaluma, CAGlaukos Investigative Site· Torrance, CAGlaukos Investigative Site· Colorado Springs, COGlaukos Investigative Site· Grand Junction, COGlaukos Investigative Site· Bradenton, FL

Related Studies