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

October 11, 2019 updated by: Laboratoires Thea
The purpose of this study is to assess the performance and safety of T4020 versus saline solution.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

157

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Varna, Bulgaria
        • Hospital
  • France
      • Clermont Ferrand, France, 63000
        • CHU
  • Spain
      • Vigo, Spain
        • Hospital
  • Turkey
      • Kayseri, Turkey
        • Erciyes Universitesi Tıp Fakultesi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: T4020
1 drop every other day during 5 days
Device: T4020
Placebo Comparator: Saline solution
1 drop every other day during 5 days
Device: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With Complete Healing of Corneal Epithelial Defect at Day 3
Time Frame: Day 3
Day 3
Number of Participants With Complete Healing of Corneal Epithelial Defect at Day 4
Time Frame: Day 4
Day 4

Secondary Outcome Measures

Outcome Measure
Time Frame
Corneal Epithelial Defect Size Assessment
Time Frame: Baseline and Day 5
Baseline and Day 5
Number of Participants With Treatment-emergent Adverse Events
Time Frame: Through study completion, an average of 1 month
Through study completion, an average of 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laboratoires Thea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

November 9, 2016

First Submitted That Met QC Criteria

November 28, 2016

First Posted (Estimate)

December 1, 2016

Study Record Updates

Last Update Posted (Actual)

October 22, 2019

Last Update Submitted That Met QC Criteria

October 11, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LT4020-302

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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