Cosmetic AppearanceNCT06493383
Lotrafilcon B Plano Cosmetic Contact Lenses Study
A study testing Lotrafilcon B plano cosmetic contact lenses in people with Cosmetic Appearance, run by Alcon Research at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cosmetic Appearance
- What is being tested?
- Lotrafilcon B plano cosmetic contact lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2025to May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, 76134
About this study
Official title: 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.
Read the 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
- Being tested
- Lotrafilcon B plano cosmetic contact lenses
- Keywords
- Eye color, Colored contact lenses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lotrafilcon B plano cosmetic contact lensesDevice
Commercially approved colored contact lenses worn for cosmetic purposes to alter or enhance the apparent color of the eye
| Study group | Role | What they receive |
|---|---|---|
| AIR OPTIX COLORS | Experimental | 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. Receives: Device: Lotrafilcon B plano cosmetic contact lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of corneal infiltrative events
A corneal infiltrate is a single or group of inflammatory cells in the normally clear cornea.
Measured: Up to Year 1
Incidence of microbial keratitis
Microbial keratitis is a sight-threatening infection of the cornea.
Measured: Up to Year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study startJan 2025 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Why it stopped: Information to be gathered in survey format instead of a clinical investigation.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cosmetic AppearanceStudies of the same condition, open and under way.
- More trials run by Alcon ResearchThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Lead, Vision Care, Study director, Alcon Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06493383
- Sponsor's protocol ID
- CLT354-P001
- Status last verified
- Jun 2025
- First submitted
- 2 Jul 2024
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lotrafilcon B Plano Cosmetic Contact Lenses Post-Market Clinical Follow-Up Study
- ClinicalTrials.gov ID
- NCT06493383
- Acronym / sponsor ID
- CLT354-P001
- Conditions
- Cosmetic Appearance
- Keywords
- Eye color, Colored contact lenses
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Information to be gathered in survey format instead of a clinical investigation.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Jan 2025 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 10 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AIR OPTIX COLORS | Experimental | Device: Lotrafilcon B plano cosmetic contact lensesLotrafilcon 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. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lotrafilcon B plano cosmetic contact lensesCommercially approved colored contact lenses worn for cosmetic purposes to alter or enhance the apparent color of the eye | Device | AIR OPTIX COLORS |
Primary outcome
Incidence of corneal infiltrative events
Time frame: Up to Year 1
A corneal infiltrate is a single or group of inflammatory cells in the normally clear cornea.
Incidence of microbial keratitis
Time frame: Up to Year 1
Microbial keratitis is a sight-threatening infection of the cornea.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trial Lead, Vision Care study director
Alcon Research, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lotrafilcon B plano cosmetic contact lenses in people with Cosmetic Appearance, run by Alcon Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of corneal infiltrative events (time frame: Up to Year 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.