Phase
Condition
N/ATreatment
Vehicle
lufepirsen
Clinical Study ID
Ages > 2 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Have a PCED that is at least 2 weeks in duration and refractory to one or moreconventional non-surgical standard of care (SOC) treatments
Have no clinical evidence of improvement in the PCED within 2 weeks prior torandomization despite the use of non-surgical SOC treatment
Subject must provide written informed consent (or assent)
Subjects with childbearing potential must be 1-year postmenopausal, surgicallysterilized, or have a negative urine pregnancy test
Exclusion
Exclusion Criteria:
Have a known ocular infection that is deemed to be active requiring therapeuticintervention
Present with a corneal surface defect in either eye that is directly attributed toan infectious etiology (bacterial, viral, fungal and/or protozoal) that has notfully resolved and/or treatment has not been completed
Present with evidence of corneal ulceration/melting involving the posterior third ofthe stroma and/or perforation in either eye
Have a blepharitis or meibomian gland disease in the study eye that is deemed to beclinically relevant and/or active
Have a history of ocular surgery or any ocular procedure(s) not meeting thedesignated washout time
Have any other ocular disease requiring topical ocular medication in the affectedeye
Have a presence or history of any ocular or systemic disorder or condition thatcould interfere the safety or efficacy of the study treatment, or the interpretationof the study results
Have a known hypersensitivity to one of the components of the study or proceduralmedications (e.g., NEXAGON, fluorescein)
Participated in an interventional clinical drug or device trial within 28 days priorto Day 1
Use of the medications presented in the protocol that are prohibited in the study.
Study Design
Study Description
Connect with a study center
Principal Investigator
Newport Beach, California 92663
United StatesActive - Recruiting
Principal Investigator
Pasadena, California 91107
United StatesSite Not Available
Principal Investigator
Torrance, California 90505
United StatesSite Not Available
Principal Investigator
Grand Junction, Colorado 81501
United StatesSite Not Available
Principal Investigator
Atlanta, Georgia 30339
United StatesSite Not Available
Principal Investigator
Nashville, Tennessee 37215
United StatesSite Not Available
Principal Investigator
San Antonio, Texas 78238
United StatesSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.