NCT01797783

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2013

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

February 21, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 25, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

May 23, 2014

Completed
Last Updated

May 23, 2014

Status Verified

April 1, 2014

Enrollment Period

2 months

First QC Date

February 21, 2013

Results QC Date

April 25, 2014

Last Update Submit

April 25, 2014

Conditions

MyopiaAmetropiaPresbyopiaRefractive Error

Keywords

MyopiaPresbyopiaRefractive errorContact lensesMultifocal

Outcome Measures

Primary Outcomes (1)

  • Subjective Overall Vision

    The participant was instructed to, "Please rate the aggregate of distance, intermediate, and near vision quality. Fill in the circle below the number that indicates your selection. Rate eyes together, marking only 1 circle for both eyes. Higher numbers mean better vision." The response was recorded on a continuous scale from 1-10 (1=poor, 10=excellent).

    Up to Day 30

Secondary Outcomes (2)

  • Binocular Snellen Visual Acuity (VA) at Distance With Study Lenses

    Up to Day 30

  • Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses

    Up to Day 30

Study Arms (2)

DAILIES® AquaComfort Plus® Multifocal

EXPERIMENTAL

Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis

Device: Nelfilcon A multifocal contact lens with comfort additive

Focus® DAILIES® Progressives

ACTIVE COMPARATOR

Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis

Device: Nelfilcon A multifocal contact lens

Interventions

Nelfilcon A multifocal contact lens with comfort additiveDEVICE
DAILIES® AquaComfort Plus® Multifocal
Nelfilcon A multifocal contact lensDEVICE
Focus® DAILIES® Progressives

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

MyopiaRefractive ErrorsPresbyopia

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

Title
Stacie Cummings, O.D.
Organization
Alcon Research, Ltd.
alcon.medinfo@alcon.com
1-888-451-3937

Study Officials

  • Justin Webb, O.D.

    Alcon Research

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2013

First Posted

February 25, 2013

Study Start

February 1, 2013

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

May 23, 2014

Results First Posted

May 23, 2014

Record last verified: 2014-04