Clinical Comparison of Two Marketed Reusable Cosmetic Contact Lenses

NCT ID: NCT03755882

Last Updated: 2020-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-05
• Study Completion Date: 2018-12-26

Brief Summary

This will be a 4-visit, multi-site, randomized, brand-masked, bilateral, 2×2 crossover study. If a subject is found to meet all eligibility criteria, they will be randomized to one of two lens wear sequences. Each lens type will be worn for approximately 2 weeks.

Conditions

Visual Acuity

Study Design

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

Study Groups

TEST/CONTROL

Female subjects between the ages of 18 to 29 years who are habitual reusable soft cosmetic contact lens wearers will be randomized into one of two lens sequences.

Group Type: EXPERIMENTAL

ACUVUE® DEFINE™ Vivid Style

Intervention Type: DEVICE

TEST Lens

LACELLE™ Sparkling Brown

Intervention Type: DEVICE

CONTROL Lens

CONTROL/TEST

Female subjects between the ages of 18 to 29 years who are habitual reusable soft cosmetic contact lens wearers will be randomized into one of two lens sequences.

Group Type: EXPERIMENTAL

ACUVUE® DEFINE™ Vivid Style

Intervention Type: DEVICE

TEST Lens

LACELLE™ Sparkling Brown

Intervention Type: DEVICE

CONTROL Lens

Interventions

ACUVUE® DEFINE™ Vivid Style

TEST Lens

Intervention Type: DEVICE

LACELLE™ Sparkling Brown

CONTROL Lens

Intervention Type: DEVICE

Other Intervention Names

etafilcon A; helifilcon A

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 (ie, willing to wear only the study lenses and not use habitual lenses during the study).

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

4. The subject's vertex corrected spherical equivalent distance refraction must be in the range of -2.00 D to -7.00 D (inclusive) in each eye.

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

6. Have spherical best corrected logMAR visual acuity (VA) of 0.18 or better in each eye.

7. 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.

8. Must be habitual reusable (2 week, or monthly), cosmetic contact lenses wearers.

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

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

Sponsors

Johnson & Johnson Vision Care, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sun Yat-Sen University Zhongshan Ophthalmic Center

Guanzhou, , China

Countries

China

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CR-6286

Identifier Type: -

Identifier Source: org_study_id