To study 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.

Phase 2

• Conditions: Health Condition 1: H188- Other specified disorders of corneaHealth Condition 2: H188- Other specified disorders of cornea

• Registration Number: CTRI/2019/08/020943
• Lead Sponsor: OcuNexus Therapeutics Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-10-09
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Other (Terminated)
• Sex: Not specified
• Target Recruitment: 33

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified