Evaluation of A Marketed Silicone Hydrogel Spherical Lens Used for Monovision Correction of Presbyopia

NCT ID: NCT04073186

Last Updated: 2022-08-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 91 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-07
• Study Completion Date: 2020-03-20

Brief Summary

This is a single-masked, dispensing clinical trial. A total of approximately 48 myopic and 32 hyperopic eligible subjects will be targeted to complete the study. Subjects will be fit in the study lens, optimized if required and worn for approximately 2 weeks. Subjects will then have a washout period of approximately 1 week and be refit in the lenses and be dispensed for an additional 2 weeks of wear.

Conditions

Visual Acuity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ACUVUE® OASYS with Transitions™

Eligible subjects between the ages of 40 to 70 years of age and habitual wearers of soft contact lenses will be fitted with the study lens for two wearing cycles.

Group Type: EXPERIMENTAL

ACUVUE® OASYS with Transitions™

Intervention Type: DEVICE

JJVC Marketed Contact Lens

Interventions

ACUVUE® OASYS with Transitions™

JJVC Marketed Contact 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 between 40 and 70 years of age at the time of screening.

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

5. The subject must be an adapted monovision 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).

6. The subject's distance spherical equivalent refraction must be in the range of +3.50 D to -4.00 D in each eye.

7. The subject's refractive cylinder must be ≤1.00 D in each eye.

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

9. The subject must have best corrected distance 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 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, recurrent herpes simplex/zoster, Sjögren's syndrome, xerophthalmia, acne rosacea, Stevens-Johnson syndrome, and immunosuppressive diseases or any infectious diseases (e.g., hepatitis, tuberculosis).

3. Use of any of the following medications within 1 week prior to enrollment: oral retinoid isotretinoin (e.g. Accutane), oral tetracyclines, oral phenothiazines (e.g., Haldol, Mellaril, Thorazine, Elavil, Pamelor, Compazine), systemic steroids.

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

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

6. Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.

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

8. Any known hypersensitivity or allergic reaction to OPTI-FREE® Puremoist® care cleaning solution, non-preserved rewetting drop solution or sodium fluorescein.

9. History of herpetic keratitis.

10. Entropion, ectropion, chalazia, glaucoma, history of recurrent corneal erosions.

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

12. 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.

13. Any ocular infection or inflammation.

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

15. Any active or ongoing ocular or systemic allergies 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

VRC-East

Jacksonville, Florida, United States

Advanced Eyecare

Raytown, Missouri, United States

Manhattan Vision Associates

New York, New York, United States

Western Reserve Vision Care, Inc.

Beachwood, Ohio, United States

Dr. David W. Ferris & Associates

Warwick, Rhode Island, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CR-6349

Identifier Type: -

Identifier Source: org_study_id