Evaluation of Corneal Endothelium Health Following Articaine Ophthalmic Solution Administration

NCT07838129 — Phase 4, Not yet recruiting, 165 participants, Laboratoires Thea

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A Randomized, Double-Masked, Placebo-Controlled, Parallel-Group Evaluation of the Corneal Endothelium Health of Eyes Treated With Articaine Ophthalmic Solution, or Placebo

Registry	NCT07838129
Status	Not yet recruiting
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: double, other
Enrollment	165 (Estimated)
Sponsor	Laboratoires Thea (Industry)
Conditions	Healthy Cornea
Interventions	Articaine (CYKLX), Vehicle (Drug)
Dates	start 2027-01-01 (estimated), primary completion 2027-12-01 (estimated), completion 2027-12-01 (estimated), first posted 2026-09-24, last updated 2026-09-24

-Summary

The goal of this clinical trial is to evaluate the corneal endothelium health of eyes treated with articaine ophthalmic solution in adult participants.

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+Arms and interventions

Arm	Type	Interventions	Description
Articaine ophthalmic solution (CYKLX)	Experimental	Drug: Articaine (CYKLX)	The participant will be administered of Articaine ophthalmic solution
Vehicle	Placebo comparator	Drug: Vehicle	The participant will be administered of vehicle ophthalmic solution (without active substance).

Articaine (CYKLX) (Drug): Two drops of Articaine administered sequentially to the study eye.
Vehicle (Drug): Two drops of Vehicle administered sequentially to the study eye.

+Outcome measures

Primary outcomes

Corneal Endothelial Cell Density Change From Baseline to Day 90 [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.

+Eligibility

Sex: All, ages: 18 Years to any, accepts healthy volunteers

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

My Notes

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