Multifocal Lens Design Evaluation

NCT01997216 | Completed Results

• 1 other identifier: C-12-036
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Refractive Error; Presbyopia

Keywords

contact lenses; multifocal

Outcome Measures

Primary Outcomes (1)

• Mean Binocular HC/HI Visual Acuity at Near (40 cm)

  The participant read a Snellen chart at 40 centimeters with both eyes together while wearing study lenses. The Snellen acuity was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal near eyesight. A negative logMAR value denotes better visual acuity.

  Up to Hour 9

Secondary Outcomes (2)

• Mean Binocular HC/HI Visual Acuity at Distance

  Up to Hour 9

• Mean Monocular Over-refraction (OR) at Distance

  Up to Hour 9

Study Arms (2)

Delefilcon A MF, then AOAMF

OTHER

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.

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

AOAMF, then Delefilcon A MF

OTHER

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.

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

Interventions

Delefilcon A multifocal contact lens DEVICE

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

AOAMF, then Delefilcon A MF; Delefilcon A MF, then AOAMF

Lotrafilcon B multifocal contact lens DEVICE

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

Also known as: AIR OPTIX® AQUA MULTIFOCAL, AOAMF

AOAMF, then Delefilcon A MF; Delefilcon A MF, then AOAMF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Refractive Errors; Presbyopia

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

• Title: Joachim Nick, Dipl.-Ing. (FH), Clinical Lead
• Organization: Alcon Research, Ltd.

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Joachim Nick, Dipl.-Ing

  Alcon Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2013
• First Posted: November 28, 2013
• Study Start: October 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: February 4, 2014
• Results First Posted: February 4, 2014

Record last verified: 2013-12