NCT01254760

Brief Summary

The purpose of this trial is to evaluate and compare the clinical performance of two multifocal contact lenses.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
79

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2010

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

December 1, 2010

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

December 3, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 7, 2010

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

February 17, 2012

Completed
Last Updated

July 10, 2012

Status Verified

January 1, 2012

Enrollment Period

1 month

First QC Date

December 3, 2010

Results QC Date

January 17, 2012

Last Update Submit

June 26, 2012

Conditions

PresbyopiaMyopia

Outcome Measures

Primary Outcomes (4)

  • End of Day Comfort

    End of day comfort was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. End of day comfort was measured on a 10-point scale, with 1 being poor and 10 being excellent.

    5 days of wear, lenses replaced daily

  • End of Day Dryness

    End of day dryness was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. End of day dryness was measured on a 10-point scale, with 1 being very dry and 10 being not dry.

    5 days of wear, lenses replaced daily

  • Handling at Removal

    Handling at removal was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. Handling at removal was measured on a 10-point scale, with 1 being poor/difficult and 10 being excellent/easy.

    5 days of wear, lenses replaced daily

  • Overall Vision

    Overall vision was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. Overall vision was measured on a 10-point scale, with 1 being poor and 10 being excellent.

    5 days of wear, lenses replaced daily

Secondary Outcomes (1)

  • Overall Fit

    Day 5, lenses replaced daily

Study Arms (2)

Investigational multifocal / Commercial multifocal

OTHER

Investigational multifocal contact lenses worn first, with commercial multifocal contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 5 days.

Device: Nelfilcon A multifocal contact lens, investigationalDevice: Nelfilcon A multifocal contact lens, commercial

Commercial multifocal / Investigational multifocal

OTHER

Commercial multifocal contact lenses worn first, with investigational multifocal contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 5 days.

Device: Nelfilcon A multifocal contact lens, investigationalDevice: Nelfilcon A multifocal contact lens, commercial

Interventions

Nelfilcon A multifocal contact lens, investigationalDEVICE

Investigational, soft, multifocal contact lens for daily wear, daily disposable use.

Commercial multifocal / Investigational multifocalInvestigational multifocal / Commercial multifocal
Nelfilcon A multifocal contact lens, commercialDEVICE

Commercially marketed, soft, multifocal contact lens FDA-approved for daily wear, daily disposable use.

Also known as: Focus® DAILIES® Progressive
Commercial multifocal / Investigational multifocalInvestigational multifocal / Commercial multifocal

Eligibility Criteria

Age41 Years - 68 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 41 to 68 (inclusive).
  • Spectacle add between +0.75 and +2.75D (inclusive).
  • Habitual spectacle prescription ≤ 1.00DC (cyl).

You may not qualify if:

  • Eye injury or surgery within twelve weeks of enrollment.
  • Pre-existing ocular irritation that would preclude contact lens fitting.
  • Currently enrolled in a clinical trial.
  • Prior refractive surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

PresbyopiaMyopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Results Point of Contact

Title
Director of Alcon Clinical
Organization
Alcon Research, Ltd.
1-800-241-7629

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
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2010

First Posted

December 7, 2010

Study Start

December 1, 2010

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

July 10, 2012

Results First Posted

February 17, 2012

Record last verified: 2012-01