Evaluation of Corneal Endothelium Health Following Articaine Ophthalmic Solution Administration

NCT07838129 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: LT10540-401
• Study Type: interventional
• Target: 165
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Outcome Measures

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.

  Baseline and Day 90 post-IP administration

Study Arms (2)

Articaine ophthalmic solution (CYKLX)

EXPERIMENTAL

The participant will be administered of Articaine ophthalmic solution

Drug: Articaine (CYKLX)

Vehicle

PLACEBO COMPARATOR

The participant will be administered of vehicle ophthalmic solution (without active substance).

Drug: Vehicle

Interventions

Articaine (CYKLX) DRUG

Two drops of Articaine administered sequentially to the study eye.

Articaine ophthalmic solution (CYKLX)

Vehicle DRUG

Two drops of Vehicle administered sequentially to the study eye.

Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Laboratoires Thea: lead

MeSH Terms

Interventions

Carticaine

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2026
• First Posted: September 24, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 24, 2026

Record last verified: 2026-07