Evaluation of Corneal Endothelium Health Following Articaine Ophthalmic Solution Administration

Phase 4Not Yet RecruitingNCT07838129

Laboratoires Thea165 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

165

Conditions

Healthy Cornea

Interventions

Articaine (CYKLX)DRUG

Two drops of Articaine administered sequentially to the study eye.

VehicleDRUG

Two drops of Vehicle administered sequentially to the study eye.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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 administration

Data from ClinicalTrials.gov

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