KeratitisPhase 3NCT01794312

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

A Phase 3 study testing T4020 in people with Keratitis and Corneal Ulcer, run by Laboratoires Thea at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 to 95 years
Conditions the study is for: Keratitis, Corneal Ulcer
What is being tested?: T4020
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 152 participants
Where: 1 siteFrance
Study dates: Feb 2013to 19 Dec 2017
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 95 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

France1 site

Clinical Development Director
Clermont-Ferrand, 63000

Other trials in France

About this study

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

Conditions: Keratitis, Corneal Ulcer
Being tested: T4020, Vehicle
Medical subject headings: Keratitis, Corneal Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

T4020Device
VehicleDevice

Study groups in NCT01794312
Study group	Role	What they receive
T4020	Experimental	One drop every 2 days Receives: Device: T4020
Vehicle	Placebo comparator	One drop every 2 days Receives: Device: Vehicle

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With a Reduction in Neurotrophic the Keratitis/Ulcer Area on Day28
Reduction in neurotrophic ulcer/keratitis area of 50% or more
Measured: Day 28

Secondary outcomes (2)

Number of Participants With at Least One Treatment-emergent Adverse Event
With at least one TEAE
Measured: From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days
Best Corrected Visual Acuity
Change from baseline in far best-corrected visual acuity (LogMAR) in the pathologic eye
Measured: Baseline and Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 201319 Dec 2017

First posted18 Feb 2013 (estimated)
Study startFeb 2013
Primary completion19 Dec 2017
Study completion19 Dec 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for KeratitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 152 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01794312
Sponsor's protocol ID: LT4020-PIII-12/11
Status last verified: Oct 2019
First submitted: 25 Jan 2013
Last updated: 23 Oct 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
A Phase 1/2, Single-Dose, Multicenter, Dose Escalation, Clinical Trial to Evaluate the Safety and Efficacy of MR-146: An Open-Label Part 1 in Participants With Stage 1 or 2 Neurotrophic Keratopathy and a Double-Masked Part 2 in Participants With Stage 2 Neurotrophic Keratopathy
Neurotrophic Keratopathy
RecruitingObservational study
Validation of Interleukins and Other Cytokines Together With OCT Imaging for Rapid Infectious Keratitis Assessment
Keratitis Bacterial, Keratitis Fungal
RecruitingPhase 2
Efficacy of Locally Delivered Allogeneic Mesenchymal Stromal Cells
Corneal Ulcer
Not yet recruitingPhase 2
Trial to Evaluate the Efficacy And Safety of IVIEW-1201 In the Treatment of Fungal Keratitis
Fungal Keratitis
Not yet recruitingPhase 1
A Clinical Study to Evaluate the Safety and Effectiveness of MSCohi-O Lens in the Treatment of Immune-related Ocular Surface Diseases.
Keratitis, Autoimmunity

All Keratitis trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety Assessment of T4020 Versus Vehicule in Patients With Chronic Neurotrophic Keratitis or Corneal Ulcer
ClinicalTrials.gov ID: NCT01794312
Acronym / sponsor ID: LT4020-PIII-12/11
Conditions: Keratitis, Corneal Ulcer
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 152 participants (actual)
Lead sponsor: Laboratoires TheaIndustry (pharma, biotech, devices)
Study start: Feb 2013 (actual)
Primary completion: 19 Dec 2017 (actual)
Study completion: 19 Dec 2017 (actual)
First posted: 18 Feb 2013 (estimated)
Results: Posted 7 Oct 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
T4020	Experimental	Device: T4020One drop every 2 days
Vehicle	Placebo comparator	Device: VehicleOne drop every 2 days

Who may qualify

Ages: 18 to 95 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
T4020	Device	T4020
Vehicle	Device	Vehicle

Primary outcome

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

2 secondary outcomes

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
Best Corrected Visual Acuity
Time frame: Baseline and Day 28

Results and safety

Results posted to the registry on 7 Oct 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
T4020	74	68
Vehicle	78	67

Primary outcome: Number of Participants With a Reduction in Neurotrophic the Keratitis/Ulcer Area on Day28

Time frame: Day 28. Count of participants. Unit: Participants

Measure	T4020 n = 72	Vehicle n = 76
Value	37	44

Population analysed: Modified Intent to treat (m-ITT): All randomised patients received at least 1 IMP dose, with at least 1 baseline and 1 post-baseline efficacy assessment. For the primary outcome measure, 4 patients (2 in the T4020 and Vehicle groups) had no data for the reduction from baseline of corneal ulcer/keratitis area and were not included in this analysis

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
T4020	3 of 74 (4.1%)	25 of 74 (33.8%)	0 of 74
Vehicle	7 of 78 (9%)	27 of 78 (34.6%)	0 of 78

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Keratitis

RecruitingPhase 1/2
A Phase 1/2, Single-Dose, Multicenter, Dose Escalation, Clinical Trial to Evaluate the Safety and Efficacy of MR-146: An Open-Label Part 1 in Participants With Stage 1 or 2 Neurotrophic Keratopathy and a Double-Masked Part 2 in Participants With Stage 2 Neurotrophic Keratopathy
Neurotrophic Keratopathy
RecruitingObservational study
Validation of Interleukins and Other Cytokines Together With OCT Imaging for Rapid Infectious Keratitis Assessment
Keratitis Bacterial, Keratitis Fungal
RecruitingPhase 2
Efficacy of Locally Delivered Allogeneic Mesenchymal Stromal Cells
Corneal Ulcer
Not yet recruitingPhase 2
Trial to Evaluate the Efficacy And Safety of IVIEW-1201 In the Treatment of Fungal Keratitis
Fungal Keratitis
Not yet recruitingPhase 1
A Clinical Study to Evaluate the Safety and Effectiveness of MSCohi-O Lens in the Treatment of Immune-related Ocular Surface Diseases.
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing T4020 in people with Keratitis and Corneal Ulcer, run by Laboratoires Thea at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With a Reduction in Neurotrophic the Keratitis/Ulcer Area on Day28 (time frame: Day 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01794312.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2019.