Performance and Safety Assessment of T4020 in Managing Corneal Epithelial Defect Following Epi-off Accelerated Crosslinking

Thea Pharma

Status: Completed

Conditions: Keratoconus

Treatments: Device: Placebo; Device: T4020

Study type: Interventional

Funder types: Industry

Identifiers

NCT02979054

LT4020-302

Details and patient eligibility

About

The purpose of this study is to assess the performance and safety of T4020 versus saline solution.

Enrollment: 157 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients diagnosed with progressive keratoconus
• Patients who signed and dated informed consent

Exclusion criteria

• Patient under 18 years
• History within 1 month or any active ocular infection, ocular injury, and associated corneal ulceration and abscess
• Corneal thickness< 400µm

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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157 participants in 2 patient groups, including a placebo group

T4020

Experimental group

Description:

1 drop every other day during 5 days

Treatment:

Device: T4020

Saline solution

Placebo Comparator group

Description:

1 drop every other day during 5 days

Treatment:

Device: Placebo