Acceptance & Tolerance Study of Multifocal Contact Lenses by Functional Emmetropes

Johnson & Johnson (J&J)

Status: Completed

Conditions: Vision Correction

Treatments: Device: Multifocal Test Contact lens

Study type: Interventional

Funder types: Industry

Identifiers

NCT02394925

CR-5672

Details and patient eligibility

About

The primary objective of this study is to determine the retention rate over a two month period of vision correction in emmetropic, presbyopes fitted with multifocal contact lenses.

Enrollment: 113 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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.
4. The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 to +2.00 in each eye.
5. The subject's refractive cylinder must be less than or equal to -0.75 D in each eye.
6. The subject's ADD power must be in the range of +0.75 D to +2.50.
7. The subject must have best corrected visual acuity of 20/25 or better in each eye.

Exclusion criteria

1. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
2. Any ocular or systemic allergies that contraindicate contact lens wear.
3. Any ocular or systemic disease, autoimmune disease, or use of medication, that contraindicates contact lens wear.
4. Any ocular abnormality that may interfere with contact lens wear.
5. Use of any ocular medication, with the exception of rewetting drops.
6. Any previous intraocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.).
7. Any grade 3 or greater slit lamp findings (e.g. edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) which may contraindicate contact lens wear.
8. History of herpetic keratitis.
9. Any ocular infection or inflammation.
10. Any corneal distortion or irregular cornea.
11. History of binocular vision abnormality or strabismus.
12. Any infectious disease (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV).
13. History of diabetes.
14. Current or previous history of being prescribed a correction for distance vision.
15. Current or previous history of contact lens wear.
16. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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113 participants in 1 patient group

Multifocal Test Contact Lens

Experimental group

Description:

Subjects will wear the test lenses at least six hours per day, at least five days per week

Treatment:

Device: Multifocal Test Contact lens