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Tests treatment safety and results for Persistent Corneal Epithelial Defect
Official title A Study to Evaluate the Safety and Efficacy of NEXAGON® (Lufepirsen Ophthalmic Gel) in Subjects With PCED
ClinicalTrials.gov ID: NCT05966493
What this study is testing
What is lufepirsen high dose?
lufepirsen high dose is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for persistent corneal epithelial defect.
Also referred to as NEXAGON®.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 and older
You may be able to join if
- Have a PCED that is at least 2 weeks in duration and refractory to one or more conventional non-surgical standard of care (SOC) treatments
- Have no clinical evidence of improvement in the PCED within 2 weeks prior to randomization despite the use of non-surgical SOC treatment
- Subject must provide written informed consent (or assent)
- people with childbearing potential must be 1-year postmenopausal, surgically sterilized, or have a negative urine pregnancy test
You likely can't join if
- Have a known ocular infection that is deemed to be active requiring therapeutic intervention
- Present with a corneal surface defect in either eye that is directly attributed to an infectious etiology (bacterial, viral, fungal and/or protozoal)...
- Present with evidence of corneal ulceration/melting involving the posterior third of the stroma and/or perforation in either eye
- Have a blepharitis or meibomian gland disease in the study eye that is deemed to be clinically relevant and/or active
- Have a history of ocular surgery or any ocular procedure(s) not meeting the designated washout time
- Have any other ocular disease requiring topical ocular medication in the affected eye
See the full eligibility criteria
- Have a PCED that is at least 2 weeks in duration and refractory to one or more conventional non-surgical standard of care (SOC) treatments
- Have no clinical evidence of improvement in the PCED within 2 weeks prior to randomization despite the use of non-surgical SOC treatment
- Subject must provide written informed consent (or assent)
- people with childbearing potential must be 1-year postmenopausal, surgically sterilized, or have a negative urine pregnancy test
- Have a known ocular infection that is deemed to be active requiring therapeutic intervention
- Present with a corneal surface defect in either eye that is directly attributed to an infectious etiology (bacterial, viral, fungal and/or protozoal) that has not fully resolved and/or treatment has not been completed
- Present with evidence of corneal ulceration/melting involving the posterior third of the stroma and/or perforation in either eye
- Have a blepharitis or meibomian gland disease in the study eye that is deemed to be clinically relevant and/or active
- Have a history of ocular surgery or any ocular procedure(s) not meeting the designated washout time
- Have any other ocular disease requiring topical ocular medication in the affected eye
- Have a presence or history of any ocular or systemic disorder or condition that could interfere the safety or how well it works of the study treatment, or the interpretation of the study results
- Have a known hypersensitivity to one of the components of the study or procedural medications (e.g., NEXAGON, fluorescein)
- Participated in an treatment clinical drug or device trial within 28 days prior to Day 1
- Use of the medications presented in the protocol that are prohibited in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Dothan, Alabama, United States
- Petaluma, California, United States
- Torrance, California, United States
- Colorado Springs, Colorado, United States
- Grand Junction, Colorado, United States
- Bradenton, Florida, United States
- Fort Myers, Florida, United States
- South Miami, Florida, United States
- Atlanta, Georgia, United States
- Carmel, Indiana, United States
- Fraser, Michigan, United States
- Kansas City, Missouri, United States
- Palisades Park, New Jersey, United States
- Shelby, North Carolina, United States
- Bala-Cynwyd, Pennsylvania, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
- Madison, Wisconsin, United States
- Milwaukee, Wisconsin, United States
+ 7 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dothan, Alabama, United States; Petaluma, California, United States; Torrance, California, United States; Colorado Springs, Colorado, United States; Grand Junction, Colorado, United States; Bradenton, Florida, United States and 21 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.