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:
NCT01634659
First received: July 3, 2012
Last updated: November 27, 2013
Last verified: November 2013
  Purpose

The purpose of this study was to compare the subjective performance of DAILIES TOTAL1® daily disposable contact lenses to that of 1-DAY ACUVUE® TruEye® daily disposable contact lenses.


Condition Intervention
Myopia
Device: Delefilcon A contact lenses (DAILIES TOTAL1®)
Device: Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
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:
  • Overall Comfort [ Time Frame: Day 8 ] [ Designated as safety issue: No ]
    Overall comfort was interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 8 days of wear. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. Both eyes contributed to the mean.


Secondary Outcome Measures:
  • Overall Quality of Vision [ Time Frame: Day 8 ] [ Designated as safety issue: No ]
    Overall quality of vision was interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 8 days of wear. Overall quality of vision was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. Both eyes contributed to the mean.

  • End of Day Comfort [ Time Frame: Day 8 ] [ Designated as safety issue: No ]
    End of day comfort was interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 8 days of wear. End of day comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. Both eyes contributed to the mean.


Enrollment: 330
Study Start Date: July 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Delefilcon A, then narafilcon B
Delefilcon A contact lenses (DAILIES TOTAL1®) worn first, followed by narafilcon B contact lenses (1-DAY ACUVUE® TruEye®). Each product was worn bilaterally (ie, in both eyes) in a daily wear, daily disposable mode for 8 days.
Device: Delefilcon A contact lenses (DAILIES TOTAL1®)
Commercially marketed silicone hydrogel, single-vision contact lenses for daily wear, daily disposable use
Device: Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®)
Commercially marketed, silicone hydrogel single-vision contact lenses for daily wear, daily disposable use
Narafilcon B, then delefilcon A
Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®) worn first, followed by delefilcon A contact lenses (DAILIES TOTAL1®). Each product was worn bilaterally (ie, in both eyes) in a daily wear, daily disposable mode for 8 days.
Device: Delefilcon A contact lenses (DAILIES TOTAL1®)
Commercially marketed silicone hydrogel, single-vision contact lenses for daily wear, daily disposable use
Device: Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®)
Commercially marketed, silicone hydrogel single-vision contact lenses for daily wear, daily disposable use

  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 and HIPAA form.
  • Be current weekly/monthly replacement contact lens wearer.
  • Be willing to not sleep in contact lenses during the study period.
  • Require vision correction in both eyes, with a contact lens prescription in protocol-specified power range.
  • Have best corrected visual acuity of at least 20/25 in each eye.
  • Be willing to wear study lenses for at least 8 hours/day and at least 5 days/week.
  • Use re-wetting drops less than once per day and be willing to discontinue use of rewetting drops while wearing the study contact lenses.
  • Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

  • Be a neophyte or current wearer of daily disposable lenses.
  • Require monovision correction or use multifocal contact lenses.
  • Have any systemic or ocular disease or disorder, complicating factor, or structural abnormality that would negatively affect the conduct or outcome of the study.
  • Have a history of ocular surgery/trauma within the last 6 months.
  • Use topical ocular or systemic antibiotics within 7 days of enrollment.
  • Use topical ocular or systemic corticosteroids within 14 days of enrollment, continuing throughout the study.
  • Have participated in any other ophthalmic drug or device clinical trial within 30 days of enrollment.
  • Have habitually worn contact lenses on an extended wear basis (sleeping in habitual contact lenses for at least 2 nights per week) in the last 3 months prior to enrollment.
  • Use re-wetting drops once or more per day.
  • Other protocol-defined exclusion criteria may apply.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01634659

Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Jami Kern, MBA, PhD Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01634659     History of Changes
Other Study ID Numbers: M-12-033
Study First Received: July 3, 2012
Results First Received: September 27, 2013
Last Updated: November 27, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Alcon Research:
contact lenses
myopia

ClinicalTrials.gov processed this record on September 30, 2014