NCT01548833

Brief Summary

The purpose of this study was to compare the pre-lens tear film stability of DAILIES TOTAL1® silicone hydrogel daily disposable contact lenses with that of two other silicone hydrogel daily disposable contact lenses.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2012

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

March 1, 2012

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

March 6, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 8, 2012

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

June 24, 2013

Completed
Last Updated

June 24, 2013

Status Verified

June 1, 2013

Enrollment Period

1 month

First QC Date

March 6, 2012

Results QC Date

April 22, 2013

Last Update Submit

June 6, 2013

Conditions

Myopia

Keywords

MyopiaContact Lenses

Outcome Measures

Primary Outcomes (1)

  • Pre-Lens Non-Invasive Tear Break-Up Time (PL-NITBUT)

    The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The time required for a dry spot to appear on the corneal surface after blinking is referred to as the tear film break-up time. Circular images were projected onto the corneal surface using a CA-1000 topographer, and the tear film reflection was observed on a 30-inch flat panel monitor. PL-NITBUT was recorded at the first sign of image distortion. Three measurements were taken and averaged together. A higher number represents a longer tear film break up time.

    Day 7, 16 hours after lens insertion

Study Arms (3)

Dailies Total 1

EXPERIMENTAL

Delefilcon A, followed by narafilcon A and filcon II 3 in randomized order. Each product worn for 1 week in a daily wear, daily disposable manner.

Device: Delefilcon A contact lensDevice: Narafilcon A contact lensDevice: Filcon II 3 contact lens

TruEye

ACTIVE COMPARATOR

Narafilcon A, followed by delefilcon A and filcon II 3 in randomized order. Each product worn for 1 week in a daily wear, daily disposable manner.

Device: Delefilcon A contact lensDevice: Narafilcon A contact lensDevice: Filcon II 3 contact lens

Clariti

ACTIVE COMPARATOR

Filcon II 3, followed by narafilcon A and delefilcon A in randomized order. Each product worn for 1 week in a daily wear, daily disposable manner.

Device: Delefilcon A contact lensDevice: Narafilcon A contact lensDevice: Filcon II 3 contact lens

Interventions

Delefilcon A contact lensDEVICE

Silicone hydrogel contact lens for single use, daily disposable wear.

Also known as: DAILIES® TOTAL1™
ClaritiDailies Total 1TruEye
Narafilcon A contact lensDEVICE

Silicone hydrogel contact lens for single use, daily disposable wear.

Also known as: 1-DAY ACUVUE® TRUEYE™
ClaritiDailies Total 1TruEye
Filcon II 3 contact lensDEVICE

Silicone hydrogel contact lens for single use, daily disposable wear

Also known as: Clariti™ 1-day
ClaritiDailies Total 1TruEye

Eligibility Criteria

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

You may qualify if:

  • Be of legal age of consent and sign written Informed Consent document, or if under legal age, have written consent of parent or guardian to participate.
  • Require vision correction in both eyes.
  • Wear either daily disposable contact lenses or weekly/monthly replacement contact lenses in powers between -0.50 and -10.00 diopters, cylinder ≤0.75 diopter, no ADD correction.
  • Wear habitual contact lenses an average of 12-14 hours per day, at least 5 days per week.
  • Willing and able to wear study contact lenses 16 hours per day.
  • Able to achieve visual acuity of at least 6/7.5 in each eye with study lenses.

You may not qualify if:

  • Currently wearing DAILIES TOTAL1®, 1-DAY ACUVUE® TRUEYE™, or Clariti™ 1day contact lenses.
  • Require monovision correction.
  • Any systemic or ocular disease or disorder (refractive disorder allowed and dry eye permitted), complicating factors, or structural abnormality that would negatively affect the conduct or outcome of the study.
  • Ocular surgery/trauma within the last 6 months.
  • Topical or systemic antibiotic use within 7 days of enrollment.
  • Topical ocular or systemic corticosteroid use within 14 days of enrollment.
  • Pregnant and nursing women.
  • Participation in any other ophthalmic drug or device clinical trial within 30 days of enrollment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Results Point of Contact

Title
Jami Kern, PhD
Organization
Alcon Research, Ltd.
alcon.medinfo@alcon.com
1-888-451-3937

Study Officials

  • Jami Kern, PhD

    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
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2012

First Posted

March 8, 2012

Study Start

March 1, 2012

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

June 24, 2013

Results First Posted

June 24, 2013

Record last verified: 2013-06