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OpenTrials
Completed

NCT Number: NCT01794312

Efficacy and Safety Assessment of T4020 Versus Vehicule in Patients With Chronic Neurotrophic Keratitis or Corneal Ulcer

The purpose of this study is to assess the efficacy and safety of T4020 versus vehicle.

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Key information

Conditions

Keratitis Corneal Diseases Corneal Ulcer Eye Diseases Eye Infections Infections

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clinical Development Director

Clermont-Ferrand, 63000, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients diagnosed with one chronic keratitis/corneal ulcer
  • Patients who signed and dated informed consent

Exclusion criteria

  • Patient under 18 years
  • Patient with a perforated corneal ulcer OR any risk of immediate perforation of corneal ulcer.

Treatment and study plan

T4020

Device

Vehicle

Device

Primary outcomes

  1. Number of Participants With a Reduction in Neurotrophic the Keratitis/Ulcer Area on Day28

    Time frame: Day 28

    Reduction in neurotrophic ulcer/keratitis area of 50% or more

Secondary outcomes

  1. Number of Participants With at Least One Treatment-emergent Adverse Event

    Time frame: From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days

    With at least one TEAE

  2. Best Corrected Visual Acuity

    Time frame: Baseline and Day 28

    Change from baseline in far best-corrected visual acuity (LogMAR) in the pathologic eye

Sponsors and collaborators

Lead sponsor

Laboratoires Thea

Industry

Registry information

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Feb 18, 2013
Registry last updated
Oct 23, 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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