Clinical Evaluation of Two Cosmetic Contact Lenses

NCT ID: NCT06864858

Last Updated: 2025-11-10

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-30

Study Completion Date

2025-05-05

Brief Summary

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This is a single visit, single-masked, non-dispensing, randomized, controlled, 2×2 bilateral crossover study to evaluate visual acuity.

Detailed Description

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Conditions

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Visual Acuity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Test Lens/Control Lens

Eligible subjects will be randomized into the Test Lens/Control Lens sequence, to wear the Test Lens followed by the Control Lens in a bilateral fashion, with a washout period of 5-minutes between wear periods.

Group Type EXPERIMENTAL

etafilcon A with PVP with cosmetic pattern contact lens

Intervention Type DEVICE

Test Lens

1-DAY ACUVUE® DEFINE® with LACREON®, FRESH Honey

Intervention Type DEVICE

Control Lens

Control Lens/Test Lens

Eligible subjects will be randomized into the Control Lens/Test Lens sequence, to wear the Control Lens followed by the Test Lens in a bilateral fashion, with a washout period of 5-minutes between wear periods.

Group Type EXPERIMENTAL

etafilcon A with PVP with cosmetic pattern contact lens

Intervention Type DEVICE

Test Lens

1-DAY ACUVUE® DEFINE® with LACREON®, FRESH Honey

Intervention Type DEVICE

Control Lens

Interventions

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etafilcon A with PVP with cosmetic pattern contact lens

Test Lens

Intervention Type DEVICE

1-DAY ACUVUE® DEFINE® with LACREON®, FRESH Honey

Control Lens

Intervention Type DEVICE

Eligibility Criteria

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Exclusion Criteria

1. Be currently pregnant or lactating.
2. Have any systemic disease (eg, Sjögren's Syndrome), allergies, infectious disease (eg, hepatitis, tuberculosis), contagious immunosuppressive diseases (eg, HIV), autoimmune disease (eg rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with contact lens wear and/or participation in the study (at the investigator's discretion).
3. Use of systemic medications (eg, chronic steroid use) that are known to interfere with contact lens wear (at the investigator's discretion).
4. Have any previous, or planned (during the study), ocular surgery (eg, radial keratotomy, PRK, LASIK, etc.).
5. Have any previous history or signs of a contact lens-related corneal inflammatory event (eg, past peripheral ulcer or round peripheral scar), or any other ocular abnormality that would contraindicate contact lens wear (at the investigator's discretion).
6. Have participated in any contact lens or lens care product clinical trial within seven (7) days prior to study enrollment.
7. Be an employee (e.g., Investigator, Coordinator, Technician) or immediate family member of an employee (including partner, child, parent, grandparent, grandchild or sibling of the employee or their spouse) of the clinical site.
8. Have any ocular allergies, infections or other ocular abnormalities that are known to interfere with contact lens wear and/or participation in the study. This may include, but not be limited to entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or corneal distortion (at the investigator's discretion).
9. Have any clinically significant (Grade 3 or 4 on FDA scale) tarsal abnormalities, bulbar injection, corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Johnson & Johnson Vision Care, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Johnson & Johnson Vision Care, Inc. Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Vision Care, Inc.

Locations

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Maitland Vision Center - North Orlando Ave

Maitland, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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CR-6571

Identifier Type: -

Identifier Source: org_study_id