Evaluation of Visual Performance of Two Types of Cosmetic Contact Lenses

NCT ID: NCT04534764

Last Updated: 2021-09-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-31
• Study Completion Date: 2020-08-12

Brief Summary

This is a single visit, brand-masked, non-dispensing, 2×2 bilateral crossover study. Each subject will be bilaterally fitted with one of the two test articles in each of the study periods in a random order with a 5-minute washout period in between study lenses.

Conditions

Visual Acuity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

TEST/CONTROL

Eligible subjects that are habitual soft contact lens wearers will be randomized into lens wear sequence (Test/Control)

Group Type: EXPERIMENTAL

etafilcon A with cosmetic pattern

Intervention Type: DEVICE

TEST

1-Day Acuvue DEFINE Vivid Style

Intervention Type: DEVICE

CONTROL

CONTROL/TEST

Eligible subjects that are habitual soft contact lens wearers will be randomized into lens wear sequence (Control/Test)

Group Type: EXPERIMENTAL

etafilcon A with cosmetic pattern

Intervention Type: DEVICE

TEST

1-Day Acuvue DEFINE Vivid Style

Intervention Type: DEVICE

CONTROL

Interventions

etafilcon A with cosmetic pattern

TEST

Intervention Type: DEVICE

1-Day Acuvue DEFINE Vivid Style

CONTROL

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. Appear able and willing to adhere to the instructions set forth in this clinical Protocol.

3. Subjects between 18 and 39 (inclusive) years of age at the time of screening

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 month by self-report.

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

6. 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

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

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

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

7. 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).

8. 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

Johnson & Johnson Vision Care, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Maitland Vision Center

Maitland, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CR-6060

Identifier Type: -

Identifier Source: org_study_id