NCT01794312

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
152

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2013

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2013

Completed
7 days until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 18, 2013

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2017

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

October 7, 2019

Completed
Last Updated

October 23, 2019

Status Verified

October 1, 2019

Enrollment Period

4.9 years

First QC Date

January 25, 2013

Results QC Date

July 16, 2019

Last Update Submit

October 11, 2019

Conditions

KeratitisCorneal Ulcer

Outcome Measures

Primary Outcomes (1)

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

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

    Day 28

Secondary Outcomes (2)

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

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

  • Best Corrected Visual Acuity

    Baseline and Day 28

Study Arms (2)

T4020

EXPERIMENTAL

One drop every 2 days

Device: T4020

Vehicle

PLACEBO COMPARATOR

One drop every 2 days

Device: Vehicle

Interventions

T4020DEVICE
T4020
VehicleDEVICE
Vehicle

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Development Director

Clermont-Ferrand, 63000, France

Location

MeSH Terms

Conditions

KeratitisCorneal Ulcer

Interventions

Pharmaceutical Vehicles

Condition Hierarchy (Ancestors)

Corneal DiseasesEye DiseasesEye InfectionsInfections

Intervention Hierarchy (Ancestors)

Pharmaceutic AidsPharmaceutical PreparationsSpecialty Uses of ChemicalsChemical Actions and UsesDrug Delivery SystemsDrug TherapyTherapeutics

Results Point of Contact

Title
Clinical Development Director
Organization
Laboratoires Théa
Corentin.LECAMUS@theapharma.com
+33(0)473981414

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2013

First Posted

February 18, 2013

Study Start

February 1, 2013

Primary Completion

December 19, 2017

Study Completion

December 19, 2017

Last Updated

October 23, 2019

Results First Posted

October 7, 2019

Record last verified: 2019-10

Locations

FR(1)