Comparison of a Daily Disposable Multifocal Contact Lens to a Marketed Product

NCT ID: NCT05101252

Last Updated: 2023-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 77 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-11
• Study Completion Date: 2021-11-29

Brief Summary

This is a single-masked, two-arm, parallel-group, randomized-controlled, dispensing clinical trial to evaluate the visual performance.

Conditions

Visual Acuity

Study Design

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

Study Groups

TEST Lens

Eligible subjects who are habitual soft contact lens wearers will be randomized to the TEST Lens sequence for the duration of the study.

Group Type: ACTIVE_COMPARATOR

senofilcon A C3

Intervention Type: DEVICE

TEST Lens

CONTROL Lens

Eligible subjects who are habitual soft contact lens wearers will be randomized to the CONTROL Lens sequence for the duration of the study.

Group Type: EXPERIMENTAL

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. 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. Be at least 40 years of age and not greater than 70 years of age at the time of consent.

4. Own a wearable pair of spectacles if required for their distance vision.

5. 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. 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 or +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. Be currently pregnant or lactating.

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

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

5. Have 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 Table 9.1 for further examples.

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

8. Have a history of herpetic keratitis.

9. Have a history of irregular cornea.

10. Have a history of pathological dry eye.

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

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

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

14. Have 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. Have any current ocular infection or inflammation.

16. Have 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

Stam & Associates Eye Care

Jacksonville, Florida, United States

Sabal Eye Care

Longwood, Florida, United States

Visual Eyes

Roswell, Georgia, United States

Kannarr Eye Care

Pittsburg, Kansas, United States

Birmingham Vision Care

Bloomfield Township, Michigan, United States

Eye Associates of New York

New York, New York, United States

ProCare Vision Centers

Granville, Ohio, United States

West Bay Eye Associates

Warwick, Rhode Island, 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-6468

Identifier Type: -

Identifier Source: org_study_id