Evaluation of Investigational Daily Disposable Multifocal Contact Lenses Produced With Different Manufacturing Processes in Myopes

NCT ID: NCT04889625

Last Updated: 2022-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-21
• Study Completion Date: 2021-07-21

Brief Summary

This is a single-masked, 2×3 crossover, randomized controlled, dispensing clinical trial to evaluate the visual performance (logMAR) and subjective vision responses of the Test Lens.

Conditions

Visual Acuity

Study Design

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

Study Groups

Test/Control/Control

Eligible subjects will be randomized to one of two possible lens wear sequences, Test/Control/Control.

Group Type: EXPERIMENTAL

senofilcon A C3

Intervention Type: DEVICE

Test Lens

Dailies Total 1® Multifocal Contact Lenses

Intervention Type: DEVICE

Control Lens

Control/Test/Test

Eligible subjects will be randomized to one of two possible lens wear sequences, Control/Test/Test.

Group Type: EXPERIMENTAL

senofilcon A C3

Intervention Type: DEVICE

Test Lens

Dailies Total 1® Multifocal Contact Lenses

Intervention Type: DEVICE

Control Lens

Interventions

senofilcon A C3

Test Lens

Intervention Type: DEVICE

Dailies Total 1® Multifocal Contact Lenses

Control Lens

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Potential subjects must satisfy all 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" (Appendix E).

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 medications within 1 week prior to enrollment: oral retinoid, oral tetracyclines, anticholinergics, oral phenothiazines, oral/inhaled corticosteroids. See section 9.1 for further examples.

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 3 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. Any current ocular infection or inflammation.

16. 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

Principal Investigators

Johnson & Johnson Vision Care, Inc. Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Vision Care, Inc.

Locations

Vue Optical Boutique

Jacksonville, Florida, United States

St. Johns Eye Associates

Saint Augustine, Florida, United States

Sacco Eye Group

Vestal, New York, United States

Procare Vision Centers

Granville, Ohio, United States

Gulf Coast Vision Center

Houston, Texas, United States

Tyler Eye Associates

Tyler, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CR-6444

Identifier Type: -

Identifier Source: org_study_id