Evaluation of a New Daily Disposable Multifocal Contact Lens Design

NCT01951573 | Completed Results

• 1 other identifier: C-13-011
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to demonstrate non-inferiority of a new daily disposable multifocal contact lens in plus powers against the commercially available AIR OPTIX® AQUA MULTIFOCAL (AOAMF) lens in high contrast/high illumination (HC/HI) near visual acuity (VA).

Conditions

Presbyopia; Hyperopia; Refractive Error

Keywords

contact lenses; multifocal; daily disposable; silicone hydrogel; presbyopia

Outcome Measures

Primary Outcomes (1)

• High Contrast/High Illumination (HC/HI) Binocular Visual Acuity (VA) at Near

  Near VA was assessed binocularly (both eyes together) at 40 centimeters, with over-refraction (OR), if necessary, and measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity, with a negative value denoting better than 20/20 visual acuity.

  Dispense (Day 1), Hour 9

Secondary Outcomes (2)

• HC/HI Binocular VA at Distance

  Dispense (Day 1), Hour 9

• Over-refraction (OR) Monocular at Distance

  Dispense (Day 1), Hour 9

Study Arms (2)

Delefilcon A MF, then AOAMF

OTHER

Delefilcon A multifocal contact lenses first, followed by lotrafilcon B multifocal contact lenses. Each product worn bilaterally (ie, in both eyes) for 9-12 hours, with a 1-8 day washout separating the 2 wear periods.

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

AOAMF, then Delefilcon A MF

OTHER

Lotrafilcon B multifocal contact lenses first, followed by delefilcon A multifocal contact lenses. Each product worn bilaterally (ie, in both eyes) for 9-12 hours, with a 1-8 day washout separating the 2 wear periods.

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

Interventions

Delefilcon A multifocal contact lenses DEVICE

Silicone hydrogel multifocal contact lenses for daily wear, daily disposable use

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

Lotrafilcon B multifocal contact lenses DEVICE

Silicone hydrogel multifocal contact lenses with a labeled indication for daily wear and extended wear use of up to 6 days with monthly replacement

Also known as: AIR OPTIX® AQUA MULTIFOCAL

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:

• Subjects with normal eyes who are not using any ocular medication.
• Must sign the Informed Consent document.
• Habitual lens power within the range available for the study lenses (+1.00 to +3.50 diopters(D)).
• Manifest cylinder less than or equal to 0.75D.
• Best corrected distance VA greater than or equal to 20/25 in each eye.
• Existing soft contact lens (CL) wearers who wear contact lenses in both eyes at least 5 days per week.
• Presbyopic with a spectacle addition (ADD) \>0.50D and \<2.75D.

You may not qualify if:

• Any ocular disease, inflammation, or abnormality that contraindicates CL wear.
• Any use of systemic or ocular medications for which CL wear could be contraindicated.
• History of herpetic keratitis.
• History of refractive surgery or irregular cornea.
• A clinically significant dry eye that precludes CL wear.
• Participation of the subject in a clinical study (including CL or CL care product) within the previous 30 days.
• Monocular (only 1 eye with functional vision).
• History of intolerance or hypersensitivity to any component of the test articles.

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Presbyopia; Hyperopia; Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

• Title: Mary Fahmy, Head, Clinical Development, Vision Care
• Organization: Alcon Research, Ltd.

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Joachim Nick, Dipl. Ing.

  CIBA VISION GmbH

  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
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2013
• First Posted: September 26, 2013
• Study Start: October 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: December 2, 2014
• Results First Posted: December 2, 2014

Record last verified: 2014-11