Healthy CorneaPhase 4NCT07838129
Evaluation of Corneal Endothelium Health Following Articaine Ophthalmic Solution Administration
A Phase 4 study testing Articaine (CYKLX) in people with Healthy Cornea, run by Laboratoires Thea.
Trial summary
The goal of this clinical trial is to evaluate the corneal endothelium health of eyes treated with articaine ophthalmic solution in adult participants. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Cornea
- What is being tested?
- Articaine (CYKLX)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 165 participants
- Where
- No sites listed yet
- Study dates
- Jan 2027to Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to voluntarily provide written informed consent to participate in the study.
- In the Investigator's opinion, generally healthy and free from significant medical or ocular conditions.
Who cannot join
- History of ocular surgery (extraocular or intraocular) in either eye within 6 months prior to Screening Visit 1.
- History of intravitreal injection in either eye within 14 days prior to Visit 2.
About this study
Official title: A Randomized, Double-Masked, Placebo-Controlled, Parallel-Group Evaluation of the Corneal Endothelium Health of Eyes Treated With Articaine Ophthalmic Solution, or Placebo
The goal of this clinical trial is to evaluate the corneal endothelium health of eyes treated with articaine ophthalmic solution in adult participants.
- Conditions
- Healthy Cornea
- Being tested
- Articaine (CYKLX), Vehicle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Articaine (CYKLX)Drug
Two drops of Articaine administered sequentially to the study eye.
VehicleDrug
Two drops of Vehicle administered sequentially to the study eye.
| Study group | Role | What they receive |
|---|---|---|
| Articaine ophthalmic solution (CYKLX) | Experimental | The participant will be administered of Articaine ophthalmic solution Receives: Drug: Articaine (CYKLX) |
| Vehicle | Placebo comparator | The participant will be administered of vehicle ophthalmic solution (without active substance). Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal Endothelial Cell Density Change From Baseline to Day 90
The primary endpoint is the mean change from baseline in the number/density of corneal endothelial cells 90 days post treatment with articaine ophthalmic solution or placebo.
Measured: Baseline and Day 90 post-IP administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study startJan 2027 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy CorneaStudies 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laboratoires Thea
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07838129
- Sponsor's protocol ID
- LT10540-401
- Status last verified
- Jul 2026
- First submitted
- 18 Sep 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Masked, Placebo-Controlled, Parallel-Group Evaluation of the Corneal Endothelium Health of Eyes Treated With Articaine Ophthalmic Solution, or Placebo
- ClinicalTrials.gov ID
- NCT07838129
- Acronym / sponsor ID
- LT10540-401
- Conditions
- Healthy Cornea
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Laboratoires TheaIndustry (pharma, biotech, devices)
- Study start
- Jan 2027 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 24 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate the corneal endothelium health of eyes treated with articaine ophthalmic solution in adult participants.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Articaine ophthalmic solution (CYKLX) | Experimental | Drug: Articaine (CYKLX)The participant will be administered of Articaine ophthalmic solution |
| Vehicle | Placebo comparator | Drug: VehicleThe participant will be administered of vehicle ophthalmic solution (without active substance). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Able to voluntarily provide written informed consent to participate in the study.
- In the Investigator's opinion, generally healthy and free from significant medical or ocular conditions.
Key exclusion criteria (2 listed)
- History of ocular surgery (extraocular or intraocular) in either eye within 6 months prior to Screening Visit 1.
- History of intravitreal injection in either eye within 14 days prior to Visit 2.
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 |
|---|---|---|
| Articaine (CYKLX)Two drops of Articaine administered sequentially to the study eye. | Drug | Articaine ophthalmic solution (CYKLX) |
| VehicleTwo drops of Vehicle administered sequentially to the study eye. | Drug | Vehicle |
Primary outcome
Corneal Endothelial Cell Density Change From Baseline to Day 90
Time frame: Baseline and Day 90 post-IP administration
The primary endpoint is the mean change from baseline in the number/density of corneal endothelial cells 90 days post treatment with articaine ophthalmic solution or placebo.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Articaine (CYKLX) in people with Healthy Cornea, run by Laboratoires Thea.
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: opening soon, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Corneal Endothelial Cell Density Change From Baseline to Day 90 (time frame: Baseline and Day 90 post-IP administration). 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 24 Sep 2026.