KeratoconusNCT02979054
Performance and Safety Assessment of T4020 in Managing Corneal Epithelial Defect Following Epi-off Accelerated Crosslinking
A study testing T4020 in people with Keratoconus, run by Laboratoires Thea at 4 sites in 4 countries.
Trial summary
The purpose of this study is to assess the performance and safety of T4020 versus saline solution. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Keratoconus
- 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
- 157 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Dec 2016to Mar 2018
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients diagnosed with progressive keratoconus
- Patients who signed and dated informed consent
Who cannot join
- Patient under 18 years
- History within 1 month or any active ocular infection, ocular injury, and associated corneal ulceration and abscess
- Corneal thickness< 400µm
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
The purpose of this study is to assess the performance and safety of T4020 versus saline solution.
- Conditions
- Keratoconus
- Being tested
- T4020, Placebo
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T4020Device
PlaceboDevice
| Study group | Role | What they receive |
|---|---|---|
| T4020 | Experimental | 1 drop every other day during 5 days Receives: Device: T4020 |
| Saline solution | Placebo comparator | 1 drop every other day during 5 days Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Complete Healing of Corneal Epithelial Defect at Day 3
Measured: Day 3
Number of Participants With Complete Healing of Corneal Epithelial Defect at Day 4
Measured: Day 4
Secondary outcomes (2)
Corneal Epithelial Defect Size Assessment
Measured: Baseline and Day 5
Number of Participants With Treatment-emergent Adverse Events
Measured: Through study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionMar 2018
- Study completionMar 2018
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 KeratoconusStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratoires Thea
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02979054
- Sponsor's protocol ID
- LT4020-302
- Status last verified
- Oct 2019
- First submitted
- 9 Nov 2016
- Last updated
- 22 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance and Safety Assessment of T4020 in Managing Corneal Epithelial Defect Following Epi-off Accelerated Crosslinking
- ClinicalTrials.gov ID
- NCT02979054
- Acronym / sponsor ID
- LT4020-302
- Conditions
- Keratoconus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Laboratoires TheaIndustry (pharma, biotech, devices)
- Study start
- Dec 2016 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 1 Dec 2016 (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 performance and safety of T4020 versus saline solution.
Study design
- Primary purpose
- Other
- 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: T40201 drop every other day during 5 days |
| Saline solution | Placebo comparator | Device: Placebo1 drop every other day during 5 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients diagnosed with progressive keratoconus
- Patients who signed and dated informed consent
Key exclusion criteria (3 listed)
- Patient under 18 years
- History within 1 month or any active ocular infection, ocular injury, and associated corneal ulceration and abscess
- Corneal thickness< 400µm
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 |
| Placebo | Device | Saline solution |
Primary outcome
Number of Participants With Complete Healing of Corneal Epithelial Defect at Day 3
Time frame: Day 3
Number of Participants With Complete Healing of Corneal Epithelial Defect at Day 4
Time frame: Day 4
2 secondary outcomes
Corneal Epithelial Defect Size Assessment
Time frame: Baseline and Day 5
Number of Participants With Treatment-emergent Adverse Events
Time frame: Through study completion, an average of 1 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing T4020 in people with Keratoconus, run by Laboratoires Thea at 4 sites in 4 countries.
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 3 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 22 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 4 sites in Bulgaria, France, Spain, Turkey (Türkiye). 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.
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 Complete Healing of Corneal Epithelial Defect at Day 3 (time frame: Day 3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Oct 2019.