A Prospective Study of Two Daily Disposable Contact Lenses

November 25, 2013 updated by: Alcon Research

Impact of a Novel Silicone Hydrogel in Reducing Contact Lens-Related Dryness Symptoms in Existing Contact Lens Wearers

The purpose of this study was to evaluate the performance of a novel silicone hydrogel contact lens, DAILIES TOTAL1® (DT1) compared to the standard hydrogel material in 1-DAY ACUVUE® MOIST® (1DAVM) contact lens in contact lens wearers identified as having contact lens-related dryness symptoms.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Three study visits occurred over the course of 28 ± 3 days.

Study Type

Interventional

Enrollment (Actual)

62

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

14 years to 39 years (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 and HIPAA form.
  • Currently wearing soft contact lenses and identified as having contact lens-related dryness symptoms based upon responses to the Contact Lens Dry Eye Questionnaire.
  • Wearing either daily disposable contact lenses or bi-weekly/monthly replacement contact lenses, daily wear use only (no extended wear use).
  • Able to achieve distance visual acuity of at least 20/25 in each eye with study lenses in the available parameters, -0.50D to -6.00D.
  • Willing to wear study lenses for at least 8 hours/day and at least 5 days/week.
  • Willing and able to follow instructions and maintain the appointment schedule.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Neophyte or current wearer of DAILIES TOTAL1® or 1-DAY ACUVUE® MOIST™ contact lenses.
  • Requires monovision or presbyopic correction.
  • Any systemic or ocular disease or disorder complicating factors or structural abnormality that would negatively affect the conduct or outcome of the study.
  • Recent (within 7 days of enrollment) or current ocular infection, active ocular inflammation, glaucoma or preauricular lymphadenopathy.
  • Clinically significant lash or lid abnormality.
  • Systemic disease that, in the investigator's best judgment, would prohibit or confound safe contact lens wear.
  • History of ocular surgery/trauma within the last 6 months.
  • Topical or systemic antibiotics use within 7 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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DT1
Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks
Device: Delefilcon A contact lenses
Silicone hydrogel contact lenses for daily wear, daily disposable use
Other Names:
  • DAILIES TOTAL1®
Active Comparator: 1DAVM
Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks
Device: Etafilcon A contact lenses
Hydrogel contact lenses for daily wear, daily disposable use
Other Names:
  • 1-DAY ACUVUE® MOIST™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change From Baseline in Subjective Contact Lens-related Dryness Symptoms at Week 4 as Assessed by the CLDEQ
Time Frame: Day 0, Week 4
Contact lens symptoms were evaluated using the Contact Lens and Dry Eye Questionnaire (CLDEQ). The participant indicated the frequency with which 9 common contact lens-related ocular surface dryness symptoms were experienced over the previous week. Each symptom was rated on a 5-point scale (1=never, 5=constantly). Both eyes contributed to the mean. A more negative change number indicates a greater perceived improvement, namely, lessening of the symptom.
Day 0, Week 4

Collaborators and Investigators

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

Sponsor

Alcon Research

Investigators

  • Study Director: Jami Kern, Ph.D., Alcon Research

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

July 1, 2012

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

July 6, 2012

First Submitted That Met QC Criteria

July 6, 2012

First Posted (Estimate)

July 10, 2012

Study Record Updates

Last Update Posted (Estimate)

January 14, 2014

Last Update Submitted That Met QC Criteria

November 25, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A00930

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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