NCT01155726

Brief Summary

The purpose of this study is to explore the effect of masking on subjective ratings for two daily disposable contact lenses.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
134

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

May 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 2, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

May 15, 2012

Completed
Last Updated

July 10, 2012

Status Verified

April 1, 2012

Enrollment Period

9 months

First QC Date

June 30, 2010

Results QC Date

February 15, 2012

Last Update Submit

June 26, 2012

Conditions

MyopiaHyperopia

Outcome Measures

Primary Outcomes (1)

  • Average Subjective Comfort

    Participants were asked, "How would you rate your comfort with your study lenses?" and indicated their response by marking a continuum line ranging from 0=very poor comfort to 100=excellent comfort. Subjective comfort was collected at three time points (insertion, 4 hours, 8 hours) for 3 days, and the comfort ratings were averaged together.

    Insertion, 4 hours, 8 hours each: Day 1, Day 2, and Day 3

Study Arms (4)

Nelfilcon A, Masked, Unmasked

ACTIVE COMPARATOR

Nelfilcon A worn in adaptation phase (bilaterally, 30 days). Period 1: 1DAVM and DACP (masked) worn contralaterally in random assignment for 3 days. Period 2: 1DAVM and DACP (unmasked) worn contralaterally, same assignment, 3 days. All products worn in a daily wear, daily disposable mode.

Device: Nelfilcon A contact lensDevice: Nelfilcon A contact lens with comfort additive (DACP), unmaskedDevice: Nelfilcon A contact lens with comfort additive (DACP), maskedDevice: Etafilcon A contact lens with comfort additive (1DAVM), unmaskedDevice: Etafilcon A contact lens with comfort additive (1DAVM), masked

Nelfilcon A, Masked, Partially Masked

ACTIVE COMPARATOR

Nelfilcon A worn in adaptation phase (bilaterally, 30 days). Period 1: 1DAVM and DACP (masked) worn contralaterally in random assignment for 3 days. Period 2: 1DAVM and DACP (partially masked) worn contralaterally, same assignment, 3 days. All products worn in a daily wear, daily disposable mode.

Device: Nelfilcon A contact lensDevice: Nelfilcon A contact lens with comfort additive (DACP), maskedDevice: Nelfilcon A contact lens with comfort additive (DACP), partially maskedDevice: Etafilcon A contact lens with comfort additive (1DAVM), maskedDevice: Etafilcon A contact lens with comfort additive (1DAVM), partially masked

Etafilcon A, Masked, Unmasked

ACTIVE COMPARATOR

Etafilcon A worn in adaptation phase (bilaterally, 30 days). Period 1: 1DAVM and DACP (masked) worn contralaterally in random assignment for 3 days. Period 2: 1DAVM and DACP (unmasked) worn contralaterally, same assignment, 3 days. All products worn in a daily wear, daily disposable mode.

Device: Nelfilcon A contact lens with comfort additive (DACP), unmaskedDevice: Nelfilcon A contact lens with comfort additive (DACP), maskedDevice: Etafilcon A contact lensDevice: Etafilcon A contact lens with comfort additive (1DAVM), unmaskedDevice: Etafilcon A contact lens with comfort additive (1DAVM), masked

Etafilcon A, Masked, Partially Masked

ACTIVE COMPARATOR

Etafilcon A worn in adaptation phase (bilaterally, 30 days). Period 1: 1DAVM and DACP (masked) worn contralaterally in random assignment for 3 days. Period 2: 1DAVM and DACP (partially masked) worn contralaterally, same assignment, 3 days. All products worn in a daily wear, daily disposable mode.

Device: Nelfilcon A contact lens with comfort additive (DACP), maskedDevice: Nelfilcon A contact lens with comfort additive (DACP), partially maskedDevice: Etafilcon A contact lensDevice: Etafilcon A contact lens with comfort additive (1DAVM), maskedDevice: Etafilcon A contact lens with comfort additive (1DAVM), partially masked

Interventions

Nelfilcon A contact lensDEVICE

Commercially marketed, soft, hydrogel contact lens for daily wear, daily disposable use. Blister pack label and lens packaging visible to participant. Lenses inserted and removed by participant.

Also known as: Focus DAILIES®
Nelfilcon A, Masked, Partially MaskedNelfilcon A, Masked, Unmasked
Nelfilcon A contact lens with comfort additive (DACP), unmaskedDEVICE

Commercially marketed, soft, hydrogel contact lens with comfort additive for daily wear, daily disposable use. Blister pack label and lens packaging visible to participant. Lenses and removed inserted by participant.

Also known as: DAILIES® AquaComfort Plus®
Etafilcon A, Masked, UnmaskedNelfilcon A, Masked, Unmasked
Nelfilcon A contact lens with comfort additive (DACP), maskedDEVICE

Commercially marketed, soft, hydrogel contact lens for daily wear, daily disposable use. Blister pack label and packaging not visible to participant. Lenses inserted and removed by the investigator.

Also known as: DAILIES® AquaComfort Plus®
Etafilcon A, Masked, Partially MaskedEtafilcon A, Masked, UnmaskedNelfilcon A, Masked, Partially MaskedNelfilcon A, Masked, Unmasked
Nelfilcon A contact lens with comfort additive (DACP), partially maskedDEVICE

Commercially marketed, soft, hydrogel contact lens for daily wear, daily disposable use. Lens name and manufacturer on blister pack label concealed from participant. Lenses inserted and removed by the participant.

Also known as: DAILIES® AquaComfort Plus®
Etafilcon A, Masked, Partially MaskedNelfilcon A, Masked, Partially Masked
Etafilcon A contact lensDEVICE

Commercially marketed, soft, hydrogel contact lens for daily wear, daily disposable use. Blister pack label and lens packaging visible to participant. Lenses inserted and removed by participant.

Also known as: 1-DAY ACUVUE®
Etafilcon A, Masked, Partially MaskedEtafilcon A, Masked, Unmasked
Etafilcon A contact lens with comfort additive (1DAVM), unmaskedDEVICE

Commercially marketed, soft, hydrogel contact lens with comfort additive for daily wear, daily disposable use. Blister pack label and lens packaging visible to participant. Lenses inserted and removed by participant.

Also known as: 1-DAY ACUVUE® MOIST®
Etafilcon A, Masked, UnmaskedNelfilcon A, Masked, Unmasked
Etafilcon A contact lens with comfort additive (1DAVM), maskedDEVICE

Commercially marketed, soft, hydrogel contact lens for daily wear, daily disposable use. Blister pack label and packaging not visible to participant. Lenses inserted and removed by the investigator.

Also known as: 1-DAY ACUVUE® MOIST®
Etafilcon A, Masked, Partially MaskedEtafilcon A, Masked, UnmaskedNelfilcon A, Masked, Partially MaskedNelfilcon A, Masked, Unmasked
Etafilcon A contact lens with comfort additive (1DAVM), partially maskedDEVICE

Commercially marketed, soft, hydrogel contact lens for daily wear, daily disposable use. Lens name and manufacturer on blister pack label concealed from participant. Lenses inserted and removed by the participant.

Also known as: 1-DAY ACUVUE® MOIST®
Etafilcon A, Masked, Partially MaskedNelfilcon A, Masked, Partially Masked

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older.
  • Ocular exam within 2 years.
  • Currently wearing soft contact lenses on a daily wear basis.
  • Contact lens prescription between +6.00D and -10.00D.

You may not qualify if:

  • Any ocular disease.
  • Use of systemic or ocular medications that may affect ocular health.
  • Unable to achieve an acceptable fit with the study lenses.
  • Anisometropia \>1.00D or astigmatism \>0.75D.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Contact Lens Research: University of Waterloo

Waterloo, Ontario, N2L 3G1, Canada

Location

MeSH Terms

Conditions

MyopiaHyperopia

Interventions

Masks

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Intervention Hierarchy (Ancestors)

Surgical AttireEquipment and Supplies, HospitalEquipment and SuppliesProtective DevicesPersonal Protective EquipmentSurgical EquipmentManufactured MaterialsTechnology, Industry, and Agriculture

Results Point of Contact

Title
Director of Clinical Trials
Organization
Alcon Research
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
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2010

First Posted

July 2, 2010

Study Start

May 1, 2010

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

July 10, 2012

Results First Posted

May 15, 2012

Record last verified: 2012-04

Locations

CA(1)