Clinical Evaluation of Two Daily Disposable Silicone Hydrogel Contact Lenses

November 19, 2013 updated by: Alcon Research
The purpose of this crossover study was to evaluate the end-of-day comfort of two commercially available, daily disposable, silicone hydrogel contact lenses.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

123

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Fort Worth, Texas, United States, 76134
        • Contact Alcon Call Center for Trial Locations

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:

  • 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.

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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 Names:
  • 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 Names:
  • 1-DAY ACUVUE® TRUEYE™
Other: 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 Names:
  • 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 Names:
  • 1-DAY ACUVUE® TRUEYE™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Week 2

Collaborators and Investigators

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

Sponsor

Alcon Research

Investigators

  • Study Director: Camille Girault, 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

May 1, 2012

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

March 21, 2012

First Submitted That Met QC Criteria

March 21, 2012

First Posted (Estimate)

March 23, 2012

Study Record Updates

Last Update Posted (Estimate)

January 7, 2014

Last Update Submitted That Met QC Criteria

November 19, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P-347-C-019

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.

Clinical Trials on Myopia

Clinical Trials on Delefilcon A contact lenses

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lebanon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe