Acceptance & Tolerance Study of Multifocal Contact Lenses by Functional Emmetropes

• ClinicalTrials.gov Identifier: NCT02394925
• Recruitment Status: Completed
• First Posted: March 20, 2015
• Results First Posted: May 15, 2017
• Last Update Posted: June 19, 2018
• Sponsor: Johnson & Johnson Vision Care, Inc.
• Information provided by (Responsible Party): Johnson & Johnson Vision Care, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Vision Correction	Device: Multifocal Test Contact lens	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 113 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Acceptance & Tolerance Study of Multifocal Contact Lenses by Functional Emmetropes
• Actual Study Start Date: January 1, 2015
• Actual Primary Completion Date: September 1, 2015
• Actual Study Completion Date: September 1, 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: Multifocal Test Contact Lens; Subjects will wear the test lenses at least six hours per day, at least five days per week	Device: Multifocal Test Contact lens; Used in a daily wear modality; Other Name: etafilcon A

Outcome Measures

Primary Outcome Measures :

1. Proportion of Successful Contact Lens Wearers [ Time Frame: 2 months post wear ]
   Proportion of Successful contact lens wearers is based on a subject's responses to two questionnaire items, "Overall Quality of Vision" and "Overall Comfort". Each item uses a 6 response like-rt scale (0= Not Applicable, 1=Excellent, 2=Very Good, 3=Good, 4=Fair and 5=Poor). The data from each item was dichotomized into two groups. If a subject responded "Excellent", "Very Good" or "Good" then the response=1, otherwise the response=0. The proportion of subjects with response=1 was reported as the proportion of successful contact lens wearers.

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

United States, Florida

Tallahassee Eye Center

Pensacola, Florida, United States, 32503

United Kingdom

Ocular Technology Group-International

London, United Kingdom, SW1E 6AU

Sponsors and Collaborators

Johnson & Johnson Vision Care, Inc.

More Information

• Responsible Party: Johnson & Johnson Vision Care, Inc.
• ClinicalTrials.gov Identifier: NCT02394925
• Other Study ID Numbers: CR-5672
• First Posted: March 20, 2015
• Results First Posted: May 15, 2017
• Last Update Posted: June 19, 2018
• Last Verified: April 2017