Status:
WITHDRAWN
Lotrafilcon B Plano Cosmetic Contact Lenses Study
Lead Sponsor:
Alcon Research
Conditions:
Cosmetic Appearance
Eligibility:
All Genders
12+ years
Phase:
NA
Brief 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...
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 ...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
January 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2026
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06493383
Start Date
January 1 2025
End Date
May 1 2026
Last Update
June 12 2025
Active Locations (1)
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1
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134