Acceptance & Tolerance Study of Multifocal Contact Lenses by Functional Emmetropes
- Conditions
- Vision Correction
- Interventions
- Device: Multifocal Test Contact lens
- Registration Number
- NCT02394925
- Lead Sponsor
- Johnson & Johnson Vision Care, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 113
- The subject must read, understand and sign the Statement of Informed Consent and receive a fully executed copy of the form.
- The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
- The subject must be between 40 and 70 years of age.
- The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 to +2.00 in each eye.
- The subject's refractive cylinder must be less than or equal to -0.75 D in each eye.
- The subject's ADD power must be in the range of +0.75 D to +2.50.
- The subject must have best corrected visual acuity of 20/25 or better in each eye.
- Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
- Any ocular or systemic allergies that contraindicate contact lens wear.
- Any ocular or systemic disease, autoimmune disease, or use of medication, that contraindicates contact lens wear.
- Any ocular abnormality that may interfere with contact lens wear.
- Use of any ocular medication, with the exception of rewetting drops.
- Any previous intraocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.).
- 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.
- History of herpetic keratitis.
- Any ocular infection or inflammation.
- Any corneal distortion or irregular cornea.
- History of binocular vision abnormality or strabismus.
- Any infectious disease (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV).
- History of diabetes.
- Current or previous history of being prescribed a correction for distance vision.
- Current or previous history of contact lens wear.
- Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Multifocal Test Contact Lens Multifocal Test Contact lens Subjects will wear the test lenses at least six hours per day, at least five days per week
- Primary Outcome Measures
Name Time Method Proportion of Successful Contact Lens Wearers 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Tallahassee Eye Center
🇺🇸Pensacola, Florida, United States
Ocular Technology Group-International
🇬🇧London, United Kingdom
Tallahassee Eye Center🇺🇸Pensacola, Florida, United States