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OpenTrials
Completed

NCT Number: NCT02979054

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

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

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Key information

Conditions

Keratoconus Corneal Diseases Eye Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital, Varna, Bulgaria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

T4020

Device

PLACEBO

Device

Primary outcomes

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

    Time frame: Day 3

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

    Time frame: Day 4

Secondary outcomes

  1. Corneal Epithelial Defect Size Assessment

    Time frame: Baseline and Day 5

  2. Number of Participants With Treatment-emergent Adverse Events

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

Sponsors and collaborators

Lead sponsor

Laboratoires Thea

Industry

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Dec 1, 2016
Registry last updated
Oct 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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