Clinical Evaluation of Etafilcon A Contact Lenses Using a Novel Molding Process 2

NCT03701516 | Completed Results FDA Device

• 1 other identifier: CR-6307
• Study Type: interventional
• Target: 268
• Locations: 1 country
• Sites: 12

Brief Summary

This study is a multi-site, group sequential, adaptive, randomized, double-masked, 2×2 crossover design, 1-week dispensing study. Subjects will wear bilaterally both Test and Control lenses 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

Myopia

Outcome Measures

Primary Outcomes (2)

• Overall Comfort Scores

  Overall comfort 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 with a range of 0-120.

  1-week Follow-up

• Overall Vision Scores

  Overall vision was assessed using the CLUE questionnaire. CLUE is a validated 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 IRT follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.

  1-week Follow-up

Secondary Outcomes (3)

• Average Daily Wear Time

  1-week Follow-up

• LLHC LogMAR Visual Performance

  1-week Follow-up

• HLLC LogMAR Visual Performance

  1-week Follow-up

Study Arms (2)

TEST/CONTROL

EXPERIMENTAL

Subjects between the ages of 18 and 70 years of age and are habitual wearers of daily disposable contact lens wearers will be randomly assigned to the Test/Control sequence.

Device: etafilcon A with novel molding process; Device: etafilcon A with current molding process

CONTROL/TEST

EXPERIMENTAL

Subjects between the ages of 18 and 70 years of age and are habitual wearers of daily disposable contact lens wearers will be randomly assigned to the Control/Test sequence.

Device: etafilcon A with novel molding process; Device: etafilcon A with current molding process

Interventions

etafilcon A with novel molding process DEVICE

TEST Lens

CONTROL/TEST; TEST/CONTROL

etafilcon A with current molding process DEVICE

CONTROL Lens

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 lens 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 -1.00 to -4.50 D in each eye.
• The subject's refractive cylinder must be \< 0.75 D 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 (12)

EyeCenter Optometrics

Rocklin, California, 95677, United States

Location

Fleming Island Vision Center

Fleming Island, Florida, 32258, United States

Location

Bartram Eye Clinic

Jacksonville, Florida, 32258, United States

Location

Sabal Eye Care

Longwood, Florida, 32779, United States

Location

Maitland Vision Center

Maitland, Florida, 32751, United States

Location

St. Johns Eye Associates

Saint Augustine, Florida, 32092, United States

Location

Sacco Eye Group

Vestal, New York, 13850, United States

Location

ProCare Vision Centers

Granville, Ohio, 43023, United States

Location

Eyecare Professionals of Powell

Powell, Ohio, 43065, United States

Location

Primary Eyecare Group

Brentwood, Tennessee, 37027, United States

Location

Total Eye Care, PA

Memphis, Tennessee, 38119, United States

Location

Boutetourt Eyecare, LLC

Salem, Virginia, 24153, United States

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

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

BPALL@its.jnj.com

1-904-629-2289

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: October 8, 2018
• First Posted: October 10, 2018
• Study Start: September 24, 2018
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: April 27, 2022
• Results First Posted: April 27, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (12)