NCT06493383

Lotrafilcon B Plano Cosmetic Contact Lenses Study

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Accepted

Summary

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

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

• Cosmetic Appearance

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-01-01
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2024-07-10
• Last updated: 2025-06-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study