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OpenTrials
Completed

NCT Number: NCT01634659

Clinical Evaluation of Two Daily Disposable Silicone Hydrogel Contact Lenses

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.

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Delefilcon A contact lenses (DAILIES TOTAL1®)

Device

Commercially marketed silicone hydrogel, single-vision contact lenses for daily wear, daily disposable use

Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®)

Device

Commercially marketed, silicone hydrogel single-vision contact lenses for daily wear, daily disposable use

Primary outcomes

  1. Overall Comfort

    Time frame: Day 8

    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 outcomes

  1. Overall Quality of Vision

    Time frame: Day 8

    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.

  2. End of Day Comfort

    Time frame: Day 8

    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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jul 6, 2012
Registry last updated
Dec 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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