Clinical Evaluation of the Safety and Efficacy of a New Multifocal Contact Lens

Alcon

Status

Completed

Conditions

Myopia

Refractive Error

Ametropia

Presbyopia

Treatments

Device: Nelfilcon A multifocal contact lens with comfort additive

Device: Nelfilcon A multifocal contact lens

Study type

Interventional

Funder types

Industry

Identifiers

NCT01797783

C-12-054

Details and patient eligibility

About

The purpose of this study was to demonstrate substantial equivalence of the new DAILIES® AquaComfort Plus® Multifocal (DACP MF) contact lens to the commercially available Focus® DAILIES® Progressives (FDP) contact lens.

Enrollment

83 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Sign Informed Consent Document.
Presbyopic and require a spectacle add of up to and including 3.00 diopters (D).
Currently wear soft contact lenses.
Willing and able to wear multifocal contact lenses in both eyes within the available range of powers for this trial and comply with the wearing and replacement schedule.
Manifest cylinder less than or equal to 1.00 D.
Able to achieve best corrected visual acuity (BCVA) of 20/25 or better (Snellen) in each eye at distance (as determined by manifest refraction).
Able to achieve distance visual acuity of 20/40 (Snellen) or better in each eye with study lenses and deem subjective vision as satisfactory at time of dispense.
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.
Any use of systemic or ocular medications for which contact lens wear could be contraindicated.
History of corneal or refractive surgery.
Biomicroscopy findings greater than Grade 2 at baseline.
A pathologically dry eye that precludes contact lens wear.
Monocular (only one eye with functional vision).
Wear habitual contact lenses on an extended wear schedule (any number of nights of overnight wear on a regular basis).
History of intolerance or hypersensitivity to any component of the investigational products.
Concurrent participation in a contact lens or contact lens care product clinical trial or within the previous 30 days.
Eye injury or ocular or intra-ocular surgery within 6 months prior to enrollment.
Other protocol-defined exclusion criteria may apply.