CTRI/2019/08/020943OtherPhase 2
A Phase 2, randomized, prospective, double-masked, vehicle controlled study to assess the efficacy and safety of Nexagon�® (NEXAGON) applied topically in subjects with corneal persistent epithelial defects (PED) resulting from severe ocular chemical and/or thermal injuries. - EXPEDE
OcuNexus Therapeutics Inc0 sites33 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 2
- Status
- Other
- Sponsor
- Enrollment
- 33
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •1.Male and female of any age.
- •2.The presence of a non-infected, corneal persistent epithelial defect (PED) which has resulted from a severe chemical and/or thermal (burn) injury to one or both eyes.
- •3.The PED is non-responsive to current standard of care for at least 14 days from injury.
- •4.The PED measures at least 2 mm along the largest diameter at Day 1 of the Treatment Period.
- •5.Providing written informed consent and ability to comply with the visit and dosing schedule.
Exclusion Criteria
- •1.Subjects who will be unlikely to tolerate the wearing of a Bandage Contact Lens.
- •2.Have active ocular infection.
- •3.Subjects with corneal perforation or impending corneal perforation.
- •4.Subjects receiving systemic corticosteroids (equivalent to GREATER THAN 10 mg/day of prednisone) or immunosuppressive or chemotherapeutic agents unless the dose has remained unchanged for 30 days and will remain unchanged during the study.
- •5.Subjects with severe lid abnormalities or ocular conditions that contribute to the persistence of the epithelial defect.
- •6.Female subjects of childbearing potential who are pregnant, nursing, planning a pregnancy or not using an adequate and medically acceptable form of birth control.
- •7.Subjects who have participated in an interventional clinical trial within 30 days prior to Day 1.
Investigators
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