N/A
N=39
Multifocal Lens Design Evaluation
Refractive Error · Presbyopia
Bottom Line
View on ClinicalTrials.gov: NCT01997216 ↗Enrolled (actual)
39
Serious AEs
0.0%
Results posted
Feb 2014
Primary outcome: Primary: Mean Binocular HC/HI Visual Acuity at Near (40 cm) — 0.08; 0.06; 0.05; 0.05 logMAR
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Delefilcon A multifocal contact lens (Device); Lotrafilcon B multifocal contact lens (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Nov 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Binocular HC/HI Visual Acuity at Near (40 cm) |
0.08; 0.06; 0.05; 0.05 | — |
| SECONDARY Mean Binocular HC/HI Visual Acuity at Distance |
-0.06; -0.06; -0.05; -0.05 | — |
| SECONDARY Mean Monocular Over-refraction (OR) at Distance |
0.08; 0.06; 0.06; 0.03 | — |
Summary
The purpose of this study was to compare binocular high contrast, high illumination (HC/HI) visual acuity at near (40 centimeters) of new multifocal contact lenses against AIR OPTIX® AQUA MULTIFOCAL contact lenses when worn for 9 hours.
Eligibility Criteria
Inclusion Criteria
- Sign written Informed Consent document.
- Have spectacles that provide acceptable vision and be willing to wear them if unable to wear the study lenses.
- Be presbyopic with a spectacle add ≥ 0.50 diopter.
- Currently wearing soft contact lenses at least 5 days a week.
- Other protocol-specified inclusion criteria may apply
Exclusion Criteria
- Eye injury or surgery within 12 weeks of enrollment in this trial.
- Pre-existing ocular irritation that would preclude contact lens fitting.
- Currently enrolled in any clinical trial.
- Evidence of systemic or ocular abnormality, infection, or disease which is likely to affect successful wear of contact lenses (for at least 9 hours) or use of their accessory solutions as determined by the Investigator.
- Any use of medications for which contact lens wear could be contraindicated as determined by the Investigator.
- Binocular visual acuity worse than 20/25.
- Corrected by monovision.
- Other protocol-defined exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01997216). 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.