N/A
N=40
CLARITI (TM) 1-Day Multifocal Contact Lenses Performance and Acceptance Evaluation
Presbyopia Correction
Bottom Line
View on ClinicalTrials.gov: NCT02147093 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Jul 2016
Primary outcome: Primary: Distance LogMAR Visual Acuity — -0.466; -0.972; -2.842; -3.768 LogMAR
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Test (multi-focal) (Device); Control (Sphere) (Device)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson Vision Care, Inc.
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Distance LogMAR Visual Acuity |
-0.466; -0.972; -2.842; -3.768; -2.834; -3.700 | — |
| PRIMARY Near LogMAR Visual Acuity |
-1.455; -2.545; -2.151; -3.820; -1.878; -3.441 | — |
Summary
A comparative evaluation of a newly marketed multifocal contact lens with a single vision contact lens when used with near vision spectacles. The evaluation was to quantify the difference between the two test corrections.
Eligibility Criteria
Inclusion Criteria
- Age 45 years or more
- Spectacle or soft contact lens wearer
- Refraction: best sphere (corrected for back vertex distance) -6.00 Diopters (D) to +4.00 D; Astigmatism - 0.00 D to -0.75 D; Near addition for 40 cm; Medium Add: +1.50 D to +2.00 D; High Add: +2.25 D to +2.50 D
- Best spectacle corrected visual acuity of 6/9 or better in each eye
- Willingness to adhere to the instructions set forth in the clinical protocol
- Signature of the subject Informed Consent form after review of Information to Participant document.
Exclusion Criteria
- Systemic or ocular allergies which might interfere with contact lens wear
- Systemic disease which might interfere with contact lens wear
- Ocular disease which might interfere with contact lens wear (e.g. hypothesia, insufficient lacrimal secretion)
- Use of medication which might interfere with contact lens wear
- Active ocular infection
- Use of ocular medication
- Significant ocular anomaly
- Presence of two or more corneal scars in either eye
- Monovision contact lens wearers
- Pregnancy or lactation
- Any medical condition that might be prejudicial to the study
- Participants non-able to give consent or from a vulnerable group
- Infectious disease (for example, hepatitis, tuberculosis, etc.) or a contagious immunosuppressive disease (such as HIV, AIDS, etc.)
- Employees or family member of the investigational clinic (e.g. investigator, coordinator, technician)
Data sourced from ClinicalTrials.gov (NCT02147093). 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.