Clinical Evaluation of Manufacturing Processes for a Reusable Multifocal Optical Design in a Presbyopic Population

NCT ID: NCT03787472

Last Updated: 2020-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-11
• Study Completion Date: 2019-03-22

Brief Summary

The clinical study is a randomized-controlled, double-masked, crossover clinical trial with two study treatments to compare two study lens types and the initial performance, in terms of the subjective response after a period of lens dispensing. The study will last approximately 2 to 4 months.

Conditions

Visual Acuity

Study Design

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

Study Groups

Test/Control

Hyperopic subjects that are habitual soft contact lens wearers and have presbyopia will be randomized into one the sequence (Test/Control).

Group Type: EXPERIMENTAL

JJV Investigational senofilcon A Multifocal Lens1

Intervention Type: DEVICE

CONTROL

JJV Investigational senofilcon A Multifocal Lens2

Intervention Type: DEVICE

TEST

Control/Test

Hyperopic subjects that are habitual soft contact lens wearers and have presbyopia will be randomized into the sequence (Control/Test).

Group Type: EXPERIMENTAL

JJV Investigational senofilcon A Multifocal Lens1

Intervention Type: DEVICE

CONTROL

JJV Investigational senofilcon A Multifocal Lens2

Intervention Type: DEVICE

TEST

Interventions

JJV Investigational senofilcon A Multifocal Lens1

CONTROL

Intervention Type: DEVICE

JJV Investigational senofilcon A Multifocal Lens2

TEST

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.

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

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

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

7. The subject must have distance best corrected visual acuity of 20/20-3 or better in each eye.

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

9. 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 8 hours per wear day, for 1 month of more duration).

10. 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".

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. Clinically significant (Grade 3 or 4) corneal edema, corneal vascularization, corneal staining, tarsal abnormalities or bulbar injection, or any other corneal or ocular abnormalities which would contraindicate contact lens wear.

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

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

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

8. Any current ocular infection or inflammation.

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

10. Use of any of the following oral medications within 1 week prior to enrollment: oral retinoid isotretinoin (e.g. Accutane), oral tetracyclines, topical scopolamine, systemic steroids.

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

12. History of herpetic keratitis.

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

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

15. Any known hypersensitivity or allergic reaction to Optifree®Replenish® multipurpose care solution, sodium fluorescein or Eye-Cept® rewetting drop solution.

• 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

Maitland Vision Center

Maitland, Florida, United States

Advanced Eyecare

Raytown, Missouri, United States

Spectrum Eyecare

Jamestown, New York, United States

Western Reserve Vision Care, Inc

Beachwood, Ohio, United States

ProCare Vision Centers

Granville, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CR-6317

Identifier Type: -

Identifier Source: org_study_id