Lotrafilcon B Plano Cosmetic Contact Lenses Study

NCT ID: NCT06493383

Last Updated: 2025-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-31

Study Completion Date

2026-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cosmetic Appearance

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Lotrafilcon B plano cosmetic contact lenses

Intervention Type DEVICE

Commercially approved colored contact lenses worn for cosmetic purposes to alter or enhance the apparent color of the eye

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

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.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Clinical Trial Lead, Vision Care

Role: STUDY_DIRECTOR

Alcon Research, LLC

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CLT354-P001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Multifocal Lens Design Evaluation
NCT01997216 COMPLETED NA