Cosmetic Contact Lenses Post-Market Clinical Follow-up Study

Alcon

Status: Withdrawn

Conditions: Cosmetic Appearance

Treatments: Device: Nelfilcon A plano cosmetic contact lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT06517316

CLS891-P001

Details and patient eligibility

About

The purpose of this post-market study is to gather long term performance and safety data on FreshLook® One-day Colors cosmetic contact lenses and DAILIES FreshLook® ILLUMINATE cosmetic contact lenses in participants 12 years of age and older.

Full description

FreshLook® One-day Colors contact lenses and DAILIES FreshLook® ILLUMINATE contact lenses do not contain visual correction and are worn for cosmetic purposes only. 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 the study, approximately 1 year. This study will be conducted in the United States and Japan.

Sex: All

Ages: 12+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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 nelfilcon A 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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Nelfilcon A plano cosmetic contact lenses

Other group

Description:

Nelfilcon A plano cosmetic contact lenses worn in both eyes at least 5 hours per day, at least 2 days a week, for one year. The lenses will be worn in a daily wear, daily disposable modality.

Treatment:

Device: Nelfilcon A plano cosmetic contact lenses