Multifocal Lens Design Evaluation

Alcon

Status: Completed

Conditions: Refractive Error; Presbyopia

Treatments: Device: Lotrafilcon B multifocal contact lens; Device: Delefilcon A multifocal contact lens

Study type: Interventional

Funder types: Industry

Identifiers

NCT01997216

C-12-036

Details and patient eligibility

About

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.

Full description

Each participant was randomized to a specific sequence of lens wear, during which each lens type was worn bilaterally for 9 hours to compare performance characteristics.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

42 participants in 2 patient groups

Delefilcon A MF, then AOAMF

Other group

Description:

Delefilcon A multifocal contact lenses, followed by lotrafilcon B multifocal contact lenses, as randomized. Each product was worn bilaterally (in both eyes) for 9 hours. The wear periods were separated by 2 ± 1 days.

Treatment:

Device: Delefilcon A multifocal contact lens

Device: Lotrafilcon B multifocal contact lens

AOAMF, then Delefilcon A MF

Other group

Description:

Lotrafilcon B multifocal contact lenses, followed by delefilcon A multifocal contact lenses, as randomized. Each product was worn bilaterally (in both eyes) for 9 hours. The wear periods were separated by 2 ± 1 days.

Treatment:

Device: Delefilcon A multifocal contact lens

Device: Lotrafilcon B multifocal contact lens