Clinical Evaluation of Etafilcon A Contact Lenses Using a Novel Manufacturing Technology

NCT03962790 | Completed Results FDA Device

• 1 other identifier: CR-6324
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 6

Brief Summary

This study is a multi-site, randomized, double-masked, 2×2 crossover design, 1-week dispensing study. Subjects will wear both Test and Control lenses in each eye in a random order for 1-week each as a daily disposable modality with a wash-out period of 1 week between the wearing periods.

Conditions

Visual Acuity

Outcome Measures

Primary Outcomes (2)

• Overall Comfort Score

  Overall comfort score was assessed using the Contact Lens User Experience (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (standard deviation \[SD\] 20), where higher scores indicate a more favorable/positive response. A 5-point increase in an average CLUE score translates into 10% shift in the distribution of scores for the population of soft disposable contact lens wearers.

  1-Week Follow-up

• Overall Vision Score

  Overall quality of vision was assessed using the Contact Lens User Experience (CLUE) questionnaire. CLUE is a validated patient reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. A 5-point increase in an average CLUE score translates into 10% shift in the distribution of scores for the population of soft disposable contact lens wearers.

  1-Week Follow-up

Secondary Outcomes (2)

• LogMAR Visual Performance Scale

  1-Week follow-up

• Average Daily Wear Time

  1-Week follow-up

Study Arms (2)

Test/Control

EXPERIMENTAL

Eligible subjects that are habitual wearers of hydrogel daily disposable contact lenses in both eyes will be randomly assigned to one of two sequences, (Test/Control) or (Control/Test).

Device: 1-DAY ACUVUE® MOIST

Control/Test

EXPERIMENTAL

Eligible subjects that are habitual wearers of hydrogel daily disposable contact lenses in both eyes will be randomly assigned to one of two sequences, (Test/Control) or (Control/Test).

Device: 1-DAY ACUVUE® MOIST

Interventions

1-DAY ACUVUE® MOIST DEVICE

etafilcon A contact lenses made with a new manufacturing technology

Also known as: Test

Control/Test; Test/Control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.
• Must be at least 18 and not more than 70 years of age (including 70) at the time of screening.
• The subject must be a habitual and adapted wearer of hydrogel daily disposable brand contact lenses in both eyes (at least 1 month of daily wear).
• The subject must have normal eyes (i.e., no ocular medications or infections of any type).
• The subject's required spherical contact lens prescription must be in the range of -0.50 to -6.00 D in each eye.
• The subject's refractive cylinder must be \< 0.75D in each eye.
• The subject must have best corrected visual acuity of 20/25 or better in each eye.

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 (subjects who become pregnant during the study will be discontinued).
• Any systemic disease, autoimmune disease, or use of medication that may interfere with contact lens wear.
• Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
• Any ocular infection.
• Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
• Monovision or multi-focal contact lens correction.
• Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
• History of binocular vision abnormality or strabismus.
• Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV, by self-report).
• Suspicion of or recent history of alcohol or substance abuse.
• History of serious mental illness.
• History of seizures.
• Employee or immediate family member of an employee of clinical site (e.g., 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

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (6)

Maitland Vision Center

Maitland, Florida, 32751, United States

Location

Eyecare Associates, LLP

Bloomington, Illinois, 61701, United States

Location

Manhattan Vision Associates

New York, New York, 10022, United States

Location

Sacco Eye Group

Vestal, New York, 13850, United States

Location

Eyecare Professionals of Powell

Powell, Ohio, 43065, United States

Location

Frazier Vision

Tyler, Texas, 75703, United States

Location

Results Point of Contact

• Title: Brian Pall, Director Clinical Science, Vision Care
• Organization: Johnson & Johnson Vision Care

bpall@its.jnj.com

1-800-843-2020

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: May 23, 2019
• First Posted: May 24, 2019
• Study Start: May 15, 2019
• Primary Completion: July 10, 2019
• Study Completion: July 10, 2019
• Last Updated: August 12, 2020
• Results First Posted: August 12, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will share

Locations

US (6)