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

N/ACompletedNCT02979054

Laboratoires Thea157 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Enrollment

157

Conditions

Keratoconus

Interventions

T4020DEVICE

PlaceboDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

Hospital

Varna, Bulgaria

CHU

Clermont-Ferrand, France

Hospital

Vigo, Spain

Erciyes Üniversitesi Tıp Fakültesi

Kayseri, Turkey (Türkiye)

Outcomes

Primary Outcomes

Number of Participants With Complete Healing of Corneal Epithelial Defect at Day 3

Time frame: Day 3

Number of Participants With Complete Healing of Corneal Epithelial Defect at Day 4

Time frame: Day 4

Secondary Outcomes

Corneal Epithelial Defect Size Assessment

Time frame: Baseline and Day 5

Number of Participants With Treatment-emergent Adverse Events

Time frame: Through study completion, an average of 1 month

Data from ClinicalTrials.gov

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