Pre-Lens Tear Film Performance of Silicone Hydrogel Daily Disposable Contact Lenses

June 6, 2013 updated by: Alcon Research

Randomized Cross-Over Evaluation of Silicone Hydrogel Daily Disposable Soft Contact Lenses

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • 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.
  • Other protocol-defined exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Dailies Total 1
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 lens
Silicone hydrogel contact lens for single use, daily disposable wear.
Other Names:
  • DAILIES® TOTAL1™
Device: Narafilcon A contact lens
Silicone hydrogel contact lens for single use, daily disposable wear.
Other Names:
  • 1-DAY ACUVUE® TRUEYE™
Device: Filcon II 3 contact lens
Silicone hydrogel contact lens for single use, daily disposable wear
Other Names:
  • Clariti™ 1-day
ACTIVE_COMPARATOR: TruEye
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 lens
Silicone hydrogel contact lens for single use, daily disposable wear.
Other Names:
  • DAILIES® TOTAL1™
Device: Narafilcon A contact lens
Silicone hydrogel contact lens for single use, daily disposable wear.
Other Names:
  • 1-DAY ACUVUE® TRUEYE™
Device: Filcon II 3 contact lens
Silicone hydrogel contact lens for single use, daily disposable wear
Other Names:
  • Clariti™ 1-day
ACTIVE_COMPARATOR: Clariti
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 lens
Silicone hydrogel contact lens for single use, daily disposable wear.
Other Names:
  • DAILIES® TOTAL1™
Device: Narafilcon A contact lens
Silicone hydrogel contact lens for single use, daily disposable wear.
Other Names:
  • 1-DAY ACUVUE® TRUEYE™
Device: Filcon II 3 contact lens
Silicone hydrogel contact lens for single use, daily disposable wear
Other Names:
  • Clariti™ 1-day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pre-Lens Non-Invasive Tear Break-Up Time (PL-NITBUT)
Time Frame: Day 7, 16 hours after lens insertion
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcon Research

Collaborators

Aston University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (ACTUAL)

April 1, 2012

Study Completion (ACTUAL)

April 1, 2012

Study Registration Dates

First Submitted

March 6, 2012

First Submitted That Met QC Criteria

March 7, 2012

First Posted (ESTIMATE)

March 8, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

June 24, 2013

Last Update Submitted That Met QC Criteria

June 6, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A00924

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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