Clinical Evaluation of Daily Disposable Etafilcon A Cosmetic Contact Lenses (2022)

NCT ID: NCT05480514

Last Updated: 2024-01-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 89 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-27
• Study Completion Date: 2022-11-16

Brief Summary

This is a multi-site, 4-visit, brand-masked, bilateral, 2x2 cross-over dispensing study to evaluate visual acuity.

Conditions

Visual Acuity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TEST/CONTROL

Eligible subjects will be randomized to the wear sequence (TEST/CONTROL) to wear the study lenses during each dispensing period (5 to 7 days) with a wash-out period (2 to 5 days) between wears.

Group Type: EXPERIMENTAL

TEST LENS

Intervention Type: DEVICE

etafilcon A with cosmetic pattern

CONTROL LENS

Intervention Type: DEVICE

Acuvue 1-Day Define Fresh Honey

CONTROL/TEST

Eligible subjects will be randomized to the wear sequence (CONTROL/TEST) to wear the study lenses during each dispensing period (5 to 7 days) with a wash-out period (2 to 5 days) between wears.

Group Type: EXPERIMENTAL

TEST LENS

Intervention Type: DEVICE

etafilcon A with cosmetic pattern

CONTROL LENS

Intervention Type: DEVICE

Acuvue 1-Day Define Fresh Honey

Interventions

TEST LENS

etafilcon A with cosmetic pattern

Intervention Type: DEVICE

CONTROL LENS

Acuvue 1-Day Define Fresh Honey

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

Potential subjects must satisfy all of the following criteria to be enrolled in the study:

1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form

2. Females between 18 and 29 (inclusive) years of age at the time of screening

3. Appear able and willing to adhere to the instructions set forth in this clinical protocol (i.e. willing to wear only the study lenses and not use habitual lenses during the dispensing periods)

4. Be a current soft contact lens wearer in both eyes with a minimum of 6 hours/day and 5 days/week over the last 30 days by self-report

5. Be a current wearer of cosmetic/circle lenses in the last 6 months, by self-report

6. The subject must be willing to be photographed and/or video-taped

7. The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 D to -6.00 D (inclusive) in each eye

8. The subject's refractive cylinder must be less than or equal to 0.75 D (inclusive) in each eye

9. Have spherical best corrected visual acuity of 20/25 or better in each eye.

Exclusion Criteria

Potential subjects who meet any of the following criteria will be excluded from participating in the study:

1. Currently pregnant or lactating

2. 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 investigators discretion)

3. Use of systemic medications (eg, chronic steroid use) that are known to interfere with contact lens wear (at the investigators discretion)

4. Any previous, or planned (during the study) ocular surgery (eg, radial keratotomy, PRK, LASIK, etc.)

5. 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 investigators discretion).

6. Participation in any contact lens or lens care product clinical trial within seven (7) days prior to study enrollment

7. Employee or family members of clinical site (eg, Investigator, Coordinator, Technician)

8. 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 investigators discretion)

9. 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: 29 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Johnson & Johnson Vision Care, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Johnson & Johnson Vision Care, Inc. Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Vision Care, Inc.

Locations

Vital Eyecare Center Limited

Mong Kok, Kowloon, Hong Kong

Sight Enhancement Center

Yau Ma Tei, Kowloon, Hong Kong

Countries

Hong Kong

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CR-6489

Identifier Type: -

Identifier Source: org_study_id