Acceptance & Tolerance Study of Multifocal Contact Lenses by Functional Emmetropes

NCT ID: NCT02394925

Last Updated: 2018-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 113 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-01
• Study Completion Date: 2015-09-01

Brief Summary

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.

Conditions

Vision Correction

Study Design

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

Study Groups

Multifocal Test Contact Lens

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

Group Type: EXPERIMENTAL

Multifocal Test Contact lens

Intervention Type: DEVICE

Used in a daily wear modality

Interventions

Multifocal Test Contact lens

Used in a daily wear modality

Intervention Type: DEVICE

Other Intervention Names

etafilcon A

Eligibility Criteria

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.

• 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

Tallahassee Eye Center

Pensacola, Florida, United States

Ocular Technology Group-International

London, , United Kingdom

Countries

United States; United Kingdom

Other Identifiers

CR-5672

Identifier Type: -

Identifier Source: org_study_id