Multifocal Lens Design Evaluation

NCT ID: NCT01997216

Last Updated: 2014-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2012-11-30

Brief 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.

Detailed 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.

Conditions

Refractive Error; Presbyopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: DOUBLE

Study Groups

Delefilcon A MF, then AOAMF

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.

Group Type: OTHER

Delefilcon A multifocal contact lens

Intervention Type: DEVICE

Investigational silicone hydrogel contact lens dispensed in low, medium, or high ADD per current AIR OPTIX® AQUA MULTIFOCAL fitting guidelines

Lotrafilcon B multifocal contact lens

Intervention Type: DEVICE

Commercially marketed silicone hydrogel contact lens dispensed in low, medium, or high ADD per current AIR OPTIX® AQUA MULTIFOCAL fitting guidelines

AOAMF, then Delefilcon A MF

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.

Group Type: OTHER

Delefilcon A multifocal contact lens

Intervention Type: DEVICE

Investigational silicone hydrogel contact lens dispensed in low, medium, or high ADD per current AIR OPTIX® AQUA MULTIFOCAL fitting guidelines

Lotrafilcon B multifocal contact lens

Intervention Type: DEVICE

Commercially marketed silicone hydrogel contact lens dispensed in low, medium, or high ADD per current AIR OPTIX® AQUA MULTIFOCAL fitting guidelines

Interventions

Delefilcon A multifocal contact lens

Investigational silicone hydrogel contact lens dispensed in low, medium, or high ADD per current AIR OPTIX® AQUA MULTIFOCAL fitting guidelines

Intervention Type: DEVICE

Lotrafilcon B multifocal contact lens

Commercially marketed silicone hydrogel contact lens dispensed in low, medium, or high ADD per current AIR OPTIX® AQUA MULTIFOCAL fitting guidelines

Intervention Type: DEVICE

Other Intervention Names

AIR OPTIX® AQUA MULTIFOCAL; AOAMF

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joachim Nick, Dipl.-Ing

Role: STUDY_DIRECTOR

Alcon Research

Other Identifiers

C-12-036

Identifier Type: -

Identifier Source: org_study_id