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
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