N/A
Completed N=34
Evaluation of a New Daily Disposable Multifocal Contact Lens Design
Presbyopia · Hyperopia · Refractive Error
Source: ClinicalTrials.gov NCT01951573 ↗
Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Dec 2014
Primary outcomePrimary: High Contrast/High Illumination (HC/HI) Binocular Visual Acuity (VA) at Near — 0.10; 0.12; 0.08; 0.09 logMAR
Summary
The purpose of this study is to demonstrate non-inferiority of a new daily disposable multifocal contact lens in plus powers against the commercially available AIR OPTIX® AQUA MULTIFOCAL (AOAMF) lens in high contrast/high illumination (HC/HI) near visual acuity (VA).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY High Contrast/High Illumination (HC/HI) Binocular Visual Acuity (VA) at Near |
0.10; 0.12; 0.08; 0.09 | — |
| SECONDARY HC/HI Binocular VA at Distance |
-0.02; -0.03; 0.00; -0.01 | — |
| SECONDARY Over-refraction (OR) Monocular at Distance |
0.00; 0.00; 0.11; 0.09 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects with normal eyes who are not using any ocular medication.
- Must sign the Informed Consent document.
- Habitual lens power within the range available for the study lenses (+1.00 to +3.50 diopters(D)).
- Manifest cylinder less than or equal to 0.75D.
- Best corrected distance VA greater than or equal to 20/25 in each eye.
- Existing soft contact lens (CL) wearers who wear contact lenses in both eyes at least 5 days per week.
- Presbyopic with a spectacle addition (ADD) >0.50D and <2.75D.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- Any ocular disease, inflammation, or abnormality that contraindicates CL wear.
- Any use of systemic or ocular medications for which CL wear could be contraindicated.
- History of herpetic keratitis.
- History of refractive surgery or irregular cornea.
- A clinically significant dry eye that precludes CL wear.
- Participation of the subject in a clinical study (including CL or CL care product) within the previous 30 days.
- Monocular (only 1 eye with functional vision).
- History of intolerance or hypersensitivity to any component of the test articles.
- Other protocol-defined exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01951573). 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. Informational only — not medical advice.