Lotrafilcon B Plano Cosmetic Contact Lenses Study

Lotrafilcon B Plano Cosmetic Contact Lenses Post-Market Clinical Follow-Up Study

The purpose of this study is to gather long-term performance and safety data on AIR OPTIX™ COLORS (lotrafilcon B) plano cosmetic contact lenses in subjects 12 years of age and older. AIR OPTIX™ COLORS plano contact lenses do not contain visual correction and are worn for cosmetic purposes only.

Study Overview

• Status: Withdrawn
• Conditions: Cosmetic Appearance
• Intervention / Treatment: Device: Lotrafilcon B plano cosmetic contact lenses

Detailed Description

Eligible participants will receive the contact lens color of their choice (if available) to be used as intended by the manufacturer for the duration of their participation in the study, approximately 1 year.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Fort Worth, Texas, United States, 76134
      • Contact Alcon Call Center for Trial Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Key Inclusion Criteria:

• Subject and/or parents/legally authorized representative must be able to understand and sign an approved informed consent form.
• Has never worn contact lenses before, with or without refractive error correction.
• Willing to wear cosmetic contact lenses and who have expressed interest in 1 to 3 color variants of lotrafilcon B plano cosmetic contact lenses.
• Willing to wear the study lenses at least 5 hours per day for at least 2 days a week during the study.
• Best Corrected Visual Acuity (BCVA) of 20/25 or better in each eye at screening.
• Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

• Any ocular disease or condition that would contraindicate contact lens wear.
• Pregnant and lactating women.
• Any use of systemic or ocular medications that would contraindicate contact lens wear.
• Other protocol-defined exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AIR OPTIX COLORS; Lotrafilcon B plano cosmetic contact lenses worn in both eyes at least 5 hours per day, at least 2 days a week, for one year. Lenses will be replaced monthly and cleaned, rinsed, disinfected, and stored in accordance with the package labeling of the lens care products recommended by the eye care professional.	Device: Lotrafilcon B plano cosmetic contact lenses; Commercially approved colored contact lenses worn for cosmetic purposes to alter or enhance the apparent color of the eye

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of corneal infiltrative events	A corneal infiltrate is a single or group of inflammatory cells in the normally clear cornea.	Up to Year 1
Incidence of microbial keratitis	Microbial keratitis is a sight-threatening infection of the cornea.	Up to Year 1

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Clinical Trial Lead, Vision Care, Alcon Research, LLC

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: July 2, 2024
• First Submitted That Met QC Criteria: July 2, 2024
• First Posted (Actual): July 10, 2024

Study Record Updates

• Last Update Posted (Actual): June 12, 2025
• Last Update Submitted That Met QC Criteria: June 10, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Eye color; Colored contact lenses
• Other Study ID Numbers: CLT354-P001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No