N/A
N=276
Evaluation of the Performance of Investigational Contact Lenses in a Presbyopic Population
Presbyopia
Bottom Line
View on ClinicalTrials.gov: NCT01763047 ↗Enrolled (actual)
276
Serious AEs
0.0%
Results posted
Jun 2016
Primary outcome: Primary: Binocular Distance Visual Acuity (LogMAR) — -0.068; -0.058; -0.109; -0.107 LogMAR
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- etafilcon A (Device); lotrafilcon B (Device)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson Vision Care, Inc.
- Primary completion
- Feb 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Binocular Distance Visual Acuity (LogMAR) |
-0.068; -0.058; -0.109; -0.107 | — |
| PRIMARY Binocular Near Visual Acuity (logMAR) |
0.063; 0.082; 0.048; 0.043 | — |
| PRIMARY Percentage of Eyes With Corneal Staining Grade 3 or Higher |
0.0; 0.0; 0.0; 0.0 | — |
| PRIMARY Percentage of Eyes With Limbal Conjunctival Redness Grade 3 or Higher |
0.0; 0.0; 0.0; 0.0 | — |
| PRIMARY Percentage of Eyes With Bulbar Conjunctival Redness Grade 3 or Higher |
0.0; 0.0; 0.0; 0.0 | — |
| PRIMARY CLUE Overall Quality of Vision Using the Contact Lens User Experience (CLUE)TM Questionnaire |
46.48; 44.79; 47.74; 50.17 | — |
Summary
The objective of this study is to evaluate the performance of a novel multifocal lens system.
Eligibility Criteria
Inclusion Criteria
- Subjects must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
- Subjects must appear able and willing to adhere to the instructions set forth in the clinical protocol.
- Subjects must be between 40 and 70 years of age.
- Subjects' spherical equivalent distance refraction must be in the range of -3.75 to +3.75 in each eye.
- Subjects' refractive cylinder must be less than or equal to 0.75D in each eye.
- Subjects' ADD power must be in the range of +0.75 to +2.50D in each eye.
- Subjects' must have the best corrected visual acuity of 20/20-3 or better in each eye.
- Subjects' should own a wearable pair of spectacles.
- Subjects' must be an adapted 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 or more duration).
- Subjects' must respond positively to at least on symptom on the "Presbyopis Symptoms Questionnaire" or already be wearing a presbyopic contact lens correction (e.g. reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.).
Exclusion Criteria
- Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
- Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
- Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear.
- 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.
- Any ocular infection.
- Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
- History of binocular vision abnormality or strabismus.
- Any infectious disease (e.g. hepatitis, tuberculosis) or contagious immunosuppressive disease (e.g. HIV).
- History of diabetes.
- Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.
Data sourced from ClinicalTrials.gov (NCT01763047). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.