Evaluation of a Daily Disposable Novel Multifocal Contact Lens in a Myopic Population

NCT ID: NCT04310566

Last Updated: 2022-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-21
• Study Completion Date: 2020-03-28

Brief Summary

This is a single-masked, crossover, randomized-controlled, dispensing clinical trial. A total of approximately 70 myopic eligible subjects will be targeted to complete the study.

Conditions

Visual Acuity

Study Design

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

Study Groups

Test/Control

Eligible subjects that are habitual soft contact lenses will be randomized into one of the two possible lens wear sequences: Test/Control or Control/Test

Group Type: EXPERIMENTAL

JJVC Investigational Multifocal Contact Lens (senofilcon A c3)

Intervention Type: DEVICE

TEST

Dailies Total 1® Multifocal Contact Lens

Intervention Type: DEVICE

CONTROL

Control/Test

Eligible subjects that are habitual soft contact lenses will be randomized into one of the two possible lens wear sequences: Test/Control or Control/Test

Group Type: EXPERIMENTAL

JJVC Investigational Multifocal Contact Lens (senofilcon A c3)

Intervention Type: DEVICE

TEST

Dailies Total 1® Multifocal Contact Lens

Intervention Type: DEVICE

CONTROL

Interventions

JJVC Investigational Multifocal Contact Lens (senofilcon A c3)

TEST

Intervention Type: DEVICE

Dailies Total 1® Multifocal Contact Lens

CONTROL

Intervention Type: DEVICE

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. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.

3. The subject must be at least 40 years of age and not greater than 70 years of age at the time of consent.

4. Subjects must own a wearable pair of spectacles if required for their distance vision.

5. The subject must be an adapted soft contact lens wearer in both eyes (i.e. worn lenses a minimum of 2 days per week for at least 6 hours per wear day, for 1 month or more duration).

6. The subject must either already be wearing a presbyopic contact lens correction (e.g., reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or, if not respond positively to at least one symptom on the "Presbyopic Symptoms Questionnaire".

7. The subject's distance spherical equivalent refraction must be in the range of -1.25 D to -3.75 D in each eye.

8. The subject's refractive cylinder must be ≤0.75 D in each eye.

9. The subject's ADD power must be in the range of +0.75 D to +2.50 D.

10. The subject must have distance best corrected visual acuity of 20/20-3 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.

2. Any active or ongoing ocular or systemic allergies that may interfere with contact lens wear.

3. Any active or ongoing systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. This may include, but not be limited to, diabetes, hyperthyroidism, Sjögren's syndrome, xerophthalmia, acne rosacea, Stevens-Johnson syndrome, and immunosuppressive diseases or any infectious diseases (e.g. hepatitis, tuberculosis).

4. Any previous, or planned, ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, lid procedures, cataract surgery, retinal surgery, etc.).

5. A history of amblyopia, strabismus or binocular vision abnormality.

6. Use of any of the following oral medications within 2 weeks prior to enrollment: oral retinoids, oral tetracyclines, anticholinergics, systemic/topical steroids. See section 9.1 for additional details regarding excluded systemic medications.

7. Use of any ocular medication, with the exception of rewetting drops.

8. History of herpetic keratitis.

9. History of irregular cornea.

10. History of pathological dry eye.

11. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.

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

13. Any known hypersensitivity or allergic reaction to non-preserved rewetting drop solutions or sodium fluorescein.

14. Clinically significant (Grade 2 or greater) corneal edema, corneal vascularization, corneal staining, tarsal abnormalities or bulbar injection, or any other corneal or ocular abnormalities which would contraindicate contact lens wear.

15. Entropion, ectropion, extrusions, chalazia, recurrent styes, dry eye, glaucoma, history of recurrent corneal erosions.

16. Any current ocular infection or inflammation.

17. Any current ocular abnormality that may interfere with contact lens wear.

• Minimum Eligible Age: 40 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

Dr. James Weber & Associates, PA

Jacksonville, Florida, United States

VRC-East

Jacksonville, Florida, United States

Maitland Vision Center

Maitland, Florida, United States

Kannarr Eye Care

Pittsburg, Florida, United States

Visual Eyes

Roswell, Georgia, United States

ProCare Vision Centers

Granville, Ohio, United States

West Bay Eye Associates

Warwick, Rhode Island, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CR-6385

Identifier Type: -

Identifier Source: org_study_id