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NCT02979054 Clinical Trial

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

Keratoconus Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02979054
Other study ID # LT4020-302
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 2016
Est. completion date March 2018

Study information
Verified date October 2019
Source Laboratoires Thea
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 157
Est. completion date March 2018
Est. primary completion date March 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• T4020

• Placebo

Locations
Country Name City State
Bulgaria Hospital Varna
France CHU Clermont Ferrand
Spain Hospital Vigo
Turkey Erciyes Üniversitesi Tip Fakültesi Kayseri

Sponsors (1)
Lead Sponsor Collaborator
Laboratoires Thea

Countries where clinical trial is conducted

Bulgaria,  France,  Spain,  Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Participants With Complete Healing of Corneal Epithelial Defect at Day 3 Day 3
Primary Number of Participants With Complete Healing of Corneal Epithelial Defect at Day 4 Day 4
Secondary Corneal Epithelial Defect Size Assessment Baseline and Day 5
Secondary Number of Participants With Treatment-emergent Adverse Events Through study completion, an average of 1 month
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