Evaluation of Two Marketed Multifocal Contact Lenses

NCT ID: NCT03322423

Last Updated: 2019-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-11
• Study Completion Date: 2017-11-04

Brief Summary

This is a single-masked, randomized, cross-over, dispensing, 6- visit pilot study. The purpose of this clinical study is to evaluate the performance of two marketed multifocal lenses.

Conditions

Visual Performance

Study Design

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

Study Groups

Test 1 Multifocal/Test 2 Multifocal OR Test 2 Alternative

Subjects who are habitual soft contact lens wearers, at least 40 years of age and no more than 70 years of age, will wear Test 1 Multifocal then Test 2 Multifocal OR Test 2 Alternative (based on lens optimization- subject's lens power), for approximately 8-12 days of wear with an approximately 4-8 day washout period.

Group Type: ACTIVE_COMPARATOR

Multifocal Contact Lens 1

Intervention Type: DEVICE

Dailies Total 1 Multifocal Contact Lens

Multifocal Contact Lens 2

Intervention Type: DEVICE

Biotrue ONEday for Presbyopia Contact Lenses

Spherical Contact Lens 2

Intervention Type: DEVICE

BioTrue ONEDay Spherical

Test 2 Multifocal OR Test 2 Alternative/Test 1 Multifocal

Subjects who are habitual soft contact lens wearers, at least 40 years of age and no more than 70 years of age, will wear Test 2 Multifocal OR Test 2 Alternative (based on lens optimization- subject's lens power) then Test 1 Multifocal, for approximately 8-12 days of wear with an approximately 4-8 day washout period.

Group Type: ACTIVE_COMPARATOR

Multifocal Contact Lens 1

Intervention Type: DEVICE

Dailies Total 1 Multifocal Contact Lens

Multifocal Contact Lens 2

Intervention Type: DEVICE

Biotrue ONEday for Presbyopia Contact Lenses

Spherical Contact Lens 2

Intervention Type: DEVICE

BioTrue ONEDay Spherical

Interventions

Multifocal Contact Lens 1

Dailies Total 1 Multifocal Contact Lens

Intervention Type: DEVICE

Multifocal Contact Lens 2

Biotrue ONEday for Presbyopia Contact Lenses

Intervention Type: DEVICE

Spherical Contact Lens 2

BioTrue ONEDay Spherical

Intervention Type: DEVICE

Other Intervention Names

Test 1 Multifocal , delefilcon A; Test 2 Multifocal, nesofilcon A; Test 2 Alternative, nesofilcon A

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 between 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 +3.75 D to -3.75 D.

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 in each eye.

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

8. The subject must own a pair of wearable 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 or more duration).

10. The subject must either be wearing a presbyopic contact lens correction (e.g., reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or 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. Ocular or systemic allergies or disease, or use of medication which might interfere with contact lens wear.

2. Pregnancy or lactation.

3. Currently diagnosed with diabetes.

4. Infectious diseases (e.g. hepatitis, tuberculosis) or an immune-suppressive disease (e.g. HIV).

5. 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.

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

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

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

9. Any ocular infection or inflammation.

10. Any ocular abnormality that may interfere with contact lens wear.

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 of clinical site (e.g., Investigator, Coordinator, Technician)

• 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

Golden Vision

Sarasota, Florida, United States

ABQ Eye Care

Albuquerque, New Mexico, United States

Sacco Eye Group

Vestal, New York, United States

West Bay Eye Associates

Warwick, Rhode Island, United States

Botetourt Eyecare, LLC

Salem, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CR-5860

Identifier Type: -

Identifier Source: org_study_id