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

Thea Pharma logo

Thea Pharma

Status and phase

Completed
Phase 3

Conditions

Corneal Ulcer
Keratitis

Treatments

Device: T4020
Device: Vehicle

Study type

Interventional

Funder types

Industry

Identifiers

NCT01794312
LT4020-PIII-12/11

Details and patient eligibility

About

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

Enrollment

152 patients

Sex

All

Ages

18 to 95 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

152 participants in 2 patient groups, including a placebo group

T4020
Experimental group
Description:
One drop every 2 days
Treatment:
Device: T4020
Vehicle
Placebo Comparator group
Description:
One drop every 2 days
Treatment:
Device: Vehicle

Trial documents
1

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems