Clinical Comparison of Two Marketed Reusable Cosmetic Contact Lenses

NCT03755882 | Completed Results FDA Device

• 1 other identifier: CR-6286
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Visual Performance

  Monocular visual performance (logMAR) was evaluated under 3 conditions (1.high luminance and high contrast, 2. High Lumiance Low Contrast and 3. Low Luminance High Contrast with distance goggles) at 4 meters using Early Treatment Diabetic Retinopathy Study (ETDRS) charts. Letter-by-letter results were calculated to ascertain the visual performance score for each chart read. LogMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20.

  Up to 2-Week Follow-up

Study Arms (2)

TEST/CONTROL

EXPERIMENTAL

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.

Device: ACUVUE® DEFINE™ Vivid Style; Device: LACELLE™ Sparkling Brown

CONTROL/TEST

EXPERIMENTAL

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.

Device: ACUVUE® DEFINE™ Vivid Style; Device: LACELLE™ Sparkling Brown

Interventions

ACUVUE® DEFINE™ Vivid Style DEVICE

TEST Lens

Also known as: etafilcon A

CONTROL/TEST; TEST/CONTROL

LACELLE™ Sparkling Brown DEVICE

CONTROL Lens

Also known as: helifilcon A

CONTROL/TEST; TEST/CONTROL

Eligibility Criteria

• Age: 18 Years - 29 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Potential subjects must satisfy all of the following criteria to be enrolled in the study:
• The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
• 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).
• Females between 18 and 29 (inclusive) years of age at the time of screening
• 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.
• The subject's refractive cylinder must be less than or equal to 0.75 D (inclusive) in each eye.
• Have spherical best corrected logMAR visual acuity (VA) of 0.18 or better in each eye.
• 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.
• Must be habitual reusable (2 week, or monthly), cosmetic contact lenses wearers.
• The subject must be willing to be photographed and/or video-taped

You may not qualify if:

• Potential subjects who meet any of the following criteria will be excluded from participating in the study:
• Currently pregnant or lactating
• 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).
• Use of systemic medications (eg, chronic steroid use) that are known to interfere with contact lens wear (at the investigators discretion).
• Any previous, or planned (during the study) ocular surgery (eg, radial keratotomy, PRK, LASIK, etc.)
• Participation in any contact lens or lens care product clinical trial within seven (7) days prior to study enrollment.
• Employee or family members of clinical site (eg, Investigator, Coordinator, Technician).
• 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).
• 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.

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (1)

Sun Yat-Sen University Zhongshan Ophthalmic Center

Guanzhou, China

Location

Results Point of Contact

• Title: Brian Pall, OD, MS, FAAO- Director of clinical Sciences
• Organization: Johnson & Johnson Vision Care Inc.

BPALL@its.jnj.com

904 443-1290

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2018
• First Posted: November 28, 2018
• Study Start: November 5, 2018
• Primary Completion: December 26, 2018
• Study Completion: December 26, 2018
• Last Updated: February 5, 2020
• Results First Posted: January 10, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)