Evaluation of Corneal Endothelium Health Following Articaine Ophthalmic Solution Administration
ConditionHealthy Cornea
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorLaboratoires Thea
About this trial
The goal of this clinical trial is to evaluate the corneal endothelium health of eyes treated with articaine ophthalmic solution in adult participants.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Articaine (CYKLX)
DrugTwo drops of Articaine administered sequentially to the study eye.
Vehicle
DrugTwo drops of Vehicle administered sequentially to the study eye.
Treatment groups
165 Participants
are divided into 2 treatment groupsGroup A: Articaine ophthalmic solution (CYKLX)Experimental treatment 1 intervention
Group B: VehiclePlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline and Day 90 post-IP administrationLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: