Health Condition 1: H188- Other specified disorders of cornea Health Condition 2: H188- Other specified disorders of cornea
Conditions
Interventions
Intervention1: 1. NEXAGON High Dose Concentration
Other Name: CODA001
2. NEXAGON Low Dose Concentration
Other Name: CODA001: Applied under a bandage contact lens and to the fornices of the eye on mul
Sponsors
OcuNexus Therapeutics Inc
Eligibility
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Corneal epithelial recovery, defined as a cornea that re-epithelializes by Day 28 of treatment and remains re-epithelialized for at least 28 days after initial re-epithelialization first recorded, as assessed by the investigator.Timepoint: Upto 56 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Time to corneal epithelial recovery, defined as the time from randomization to the time of the initial corneal re-epithelialization. 2.Improvement of visual acuity from baseline over the course of the study period 3.Number of NEXAGON treatment doses required for recovery of the corneal epithelium Timepoint: 1. Within 42 days 2. Up to 98 days (plus 2 days) 3. Within 42 days | — |
Countries
India, United States of America
Contacts
Public ContactVikrant Pratap Singh
Excel Life Sciences Pvt. Ltd.
Outcome results
None listed