Evaluation of Visual Performance With a Multifocal High ADD Soft Contact Lens Design

Alcon Research0 sites268 target enrollmentApril 2014

ConditionsPresbyopia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Presbyopia
Sponsor: Alcon Research
Enrollment: 268
Primary Endpoint: High Contrast Visual Acuity (HCVA) Near Monocular
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the visual performance of a new multifocal High ADD contact lens compared to the currently-marketed AIR OPTIX® AQUA MULTIFOCAL (AOAMF) High ADD Contact Lens.

Registry

clinicaltrials.gov

Start Date

April 2014

End Date

July 2014

Last Updated

10 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Alcon Research

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Must sign an Informed Consent document;
•Presbyopic and require at least 2.25 diopters (D) spectacle ADD power;
•Current or previous soft contact lens wearer;
•Not able to achieve monocular near visual acuity (VA) 0.2 logarithm of the Minimum Angle of Resolution (logMAR) \[Early Treatment of Diabetic Retinopathy Study (ETDRS)\] or better in each eye with AIR OPTIX® AQUA Multifocal (AOAMF) High ADD Contact Lenses;
•Willing and able to wear multifocal contact lenses in both eyes within the available range of powers for this trial;
•Manifest cylinder less than or equal to 1.00 D;
•Able to achieve best corrected visual acuity (BCVA) of 20/25 or better in each eye at distance (as determined by manifest refraction);
•Other protocol-defined inclusion criteria may apply.

Exclusion Criteria

•Any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear within 6 months prior to enrollment, as determined by the investigator;
•Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the investigator; or any use of topical ocular medications that would require instillation during contact lens wear;
•Any history of herpetic keratitis;
•History of corneal or refractive surgery, irregular cornea or unilateral pseudophakia;
•Biomicroscopy findings (except for corneal vascularization) that are moderate (Grade 3) or severe (Grade 4);
•Corneal vascularization that is mild (Grade 2) or higher;
•A pathologically dry eye that precludes contact lens wear;
•Monocular (only 1 eye with functional vision);
•Anisometropia ≥ 1.50 D (contact lens distance prescription);
•Clinically significant (\> 1 millimeter) anisocoria;

Outcomes

Primary Outcomes

High Contrast Visual Acuity (HCVA) Near Monocular

Time Frame: Day 1, 10 minutes after lens insertion, each product

Visual Acuity (clarity or sharpness of vision) was measured at high contrast level. HCVA was assessed monocularly (each eye separately) at 40 centimeters using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart and measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value indicates better visual acuity. Both eyes contributed to the analysis.

Secondary Outcomes

HCVA Distance Monocular(Day 1, 10 minutes after lens insertion, each product)
HCVA Intermediate Monocular(Day 1, 10 minutes after lens insertion, each product)
Low Contrast Visual Acuity (LCVA) Distance Monocular(Day 1, 10 minutes after lens insertion, each product)