Clinical Evaluation of Two Daily Disposable Silicone Hydrogel Contact Lenses

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01561560
First received: March 21, 2012
Last updated: November 19, 2013
Last verified: November 2013
  Purpose

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 Intervention
Myopia
Device: Delefilcon A contact lenses
Device: Narafilcon A contact lenses

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Two Daily Disposable Silicone Hydrogel Contact Lenses

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • End-of-day Comfort [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
    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).


Enrollment: 123
Study Start Date: May 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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™

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01561560     History of Changes
Other Study ID Numbers: P-347-C-019
Study First Received: March 21, 2012
Results First Received: November 19, 2013
Last Updated: November 19, 2013
Health Authority: United Kingdom: Research Ethics Committee
Finland: Ethics Committee
Germany: Ethics Commission

Keywords provided by Alcon Research:
DAILIES TOTAL1
contact lenses
myopia

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on April 23, 2014