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Clinical Evaluation of Two Daily Disposable Silicone Hydrogel Contact Lenses

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ClinicalTrials.gov Identifier: NCT01561560
Recruitment Status : Completed
First Posted : March 23, 2012
Results First Posted : January 7, 2014
Last Update Posted : January 7, 2014
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
The purpose of this crossover study was to evaluate the end-of-day comfort of two commercially available, daily disposable, silicone hydrogel contact lenses.

Condition or disease Intervention/treatment
Myopia Device: Delefilcon A contact lenses Device: Narafilcon A contact lenses

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 123 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Two Daily Disposable Silicone Hydrogel Contact Lenses
Study Start Date : May 2012
Primary Completion Date : August 2012
Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear
U.S. FDA Resources

Arm Intervention/treatment
DAILIES TOTAL1, then TRUEYE
Delefilcon A contact lenses worn first, followed by narafilcon A contact lenses. Each product was worn bilaterally on a daily wear, daily disposable basis for two weeks.
Device: Delefilcon A contact lenses
CE-marked, silicone hydrogel, soft contact lenses for daily wear, daily disposable use, worn bilaterally for two weeks in either Period One or Period Two
Other Name: DAILIES TOTAL1®
Device: Narafilcon A contact lenses
CE-marked, silicone hydrogel, soft contact lenses for daily wear, daily disposable use, worn bilaterally for two weeks in either Period One or Period Two
Other Name: 1-DAY ACUVUE® TRUEYE™
TRUEYE, then DAILIES TOTAL1
Narafilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product was worn bilaterally on a daily wear, daily disposable basis for two weeks.
Device: Delefilcon A contact lenses
CE-marked, silicone hydrogel, soft contact lenses for daily wear, daily disposable use, worn bilaterally for two weeks in either Period One or Period Two
Other Name: DAILIES TOTAL1®
Device: Narafilcon A contact lenses
CE-marked, silicone hydrogel, soft contact lenses for daily wear, daily disposable use, worn bilaterally for two weeks in either Period One or Period Two
Other Name: 1-DAY ACUVUE® TRUEYE™



Primary Outcome Measures :
  1. End-of-day Comfort [ Time Frame: Week 2 ]
    End-of-day comfort was interpreted and reported by the participant on a questionnaire as a single, retrospective measurement of two weeks of wear. Participants were asked, "Please rate the study lenses you have been wearing the in the following area: End-of-day comfort" and recorded their response on a continuous 1-10 Likert scale (1=poor and 10=excellent).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Sign written Informed Consent Document.
  • Currently wearing soft contact lenses in both eyes and identified as symptomatic based on questionnaire responses.
  • Currently wearing either daily disposable contact lenses or weekly/monthly replacement contact lenses.
  • Able to achieve visual acuity of at least 6/7.5 in each eye with study lenses in the available parameters.
  • Willing to wear study lenses for at least eight hours per day and at least five days per week.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Has not worn contact lenses before.
  • Currently wearing DAILIES TOTAL1 or 1-DAY ACUVUE TRUEYE contact lenses.
  • Any systemic or ocular disease or disorder that would negatively affect the conduct or outcome of the study.
  • Ocular surgery/trauma within the last six months.
  • Topical ocular or systemic use of antibiotics within seven days of enrollment.
  • Pregnant or nursing women.
  • Other protocol-defined exclusion criteria may apply.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01561560


Locations
United States, Texas
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Camille Girault Alcon Research

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01561560     History of Changes
Other Study ID Numbers: P-347-C-019
First Posted: March 23, 2012    Key Record Dates
Results First Posted: January 7, 2014
Last Update Posted: January 7, 2014
Last Verified: November 2013

Keywords provided by Alcon Research:
DAILIES TOTAL1
contact lenses
myopia

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases