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

NCT ID: NCT03962790

Last Updated: 2020-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 95 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-15
• Study Completion Date: 2019-07-10

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

Study Design

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

Study Groups

Test/Control

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).

Group Type: EXPERIMENTAL

1-DAY ACUVUE® MOIST

Intervention Type: DEVICE

etafilcon A contact lenses made with a new manufacturing technology

1-DAY ACUVUE® MOIST

Intervention Type: DEVICE

etafilcon A contact lenses made with the current manufacturing technology

Control/Test

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).

Group Type: EXPERIMENTAL

1-DAY ACUVUE® MOIST

Intervention Type: DEVICE

etafilcon A contact lenses made with a new manufacturing technology

1-DAY ACUVUE® MOIST

Intervention Type: DEVICE

etafilcon A contact lenses made with the current manufacturing technology

Interventions

1-DAY ACUVUE® MOIST

etafilcon A contact lenses made with a new manufacturing technology

Intervention Type: DEVICE

1-DAY ACUVUE® MOIST

etafilcon A contact lenses made with the current manufacturing technology

Intervention Type: DEVICE

Other Intervention Names

Test; Control

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. Must be at least 18 and not more than 70 years of age (including 70) at the time of screening.

4. 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).

5. The subject must have normal eyes (i.e., no ocular medications or infections of any type).

6. The subject's required spherical contact lens prescription must be in the range of -0.50 to -6.00 D in each eye.

7. The subject's refractive cylinder must be < 0.75D in each eye.

8. The subject must have 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 (subjects who become pregnant during the study will be discontinued).

2. Any systemic disease, autoimmune disease, or use of medication that may interfere with contact lens wear.

3. Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).

4. Any ocular infection.

5. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.

6. Monovision or multi-focal contact lens correction.

7. Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.

8. History of binocular vision abnormality or strabismus.

9. Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV, by self-report).

10. Suspicion of or recent history of alcohol or substance abuse.

11. History of serious mental illness.

12. History of seizures.

13. Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician)

14. 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

15. Any Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the Food and Drug Administration (FDA) classification scale

16. Any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 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

Eyecare Associates, LLP

Bloomington, Illinois, United States

Manhattan Vision Associates

New York, New York, United States

Sacco Eye Group

Vestal, New York, United States

Eyecare Professionals of Powell

Powell, Ohio, United States

Frazier Vision

Tyler, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CR-6324

Identifier Type: -

Identifier Source: org_study_id