Skip to main content
OpenTrials
Completed

NCT Number: NCT01636986

A Prospective Study of Two Daily Disposable Contact Lenses

The purpose of this study was to evaluate the performance of a novel silicone hydrogel contact lens, DAILIES TOTAL1® (DT1) compared to the standard hydrogel material in 1-DAY ACUVUE® MOIST® (1DAVM) contact lens in contact lens wearers identified as having contact lens-related dryness symptoms.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–43 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Three study visits occurred over the course of 28 ± 3 days.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Be of legal age of consent and sign written Informed Consent Document and HIPAA form.
  • Currently wearing soft contact lenses and identified as having contact lens-related dryness symptoms based upon responses to the Contact Lens Dry Eye Questionnaire.
  • Wearing either daily disposable contact lenses or bi-weekly/monthly replacement contact lenses, daily wear use only (no extended wear use).
  • Able to achieve distance visual acuity of at least 20/25 in each eye with study lenses in the available parameters, -0.50D to -6.00D.
  • Willing to wear study lenses for at least 8 hours/day and at least 5 days/week.
  • Willing and able to follow instructions and maintain the appointment schedule.
  • Other protocol-defined inclusion criteria may apply.

Exclusion criteria

  • Neophyte or current wearer of DAILIES TOTAL1® or 1-DAY ACUVUE® MOIST™ contact lenses.
  • Requires monovision or presbyopic correction.
  • Any systemic or ocular disease or disorder complicating factors or structural abnormality that would negatively affect the conduct or outcome of the study.
  • Recent (within 7 days of enrollment) or current ocular infection, active ocular inflammation, glaucoma or preauricular lymphadenopathy.
  • Clinically significant lash or lid abnormality.
  • Systemic disease that, in the investigator's best judgment, would prohibit or confound safe contact lens wear.
  • History of ocular surgery/trauma within the last 6 months.
  • Topical or systemic antibiotics use within 7 days of enrollment.
  • Other protocol-defined exclusion criteria may apply.

Treatment and study plan

Delefilcon A contact lenses

Device

Silicone hydrogel contact lenses for daily wear, daily disposable use

Other names: DAILIES TOTAL1®

Etafilcon A contact lenses

Device

Hydrogel contact lenses for daily wear, daily disposable use

Other names: 1-DAY ACUVUE® MOIST™

Primary outcomes

  1. Mean Change From Baseline in Subjective Contact Lens-related Dryness Symptoms at Week 4 as Assessed by the CLDEQ

    Time frame: Day 0, Week 4

    Contact lens symptoms were evaluated using the Contact Lens and Dry Eye Questionnaire (CLDEQ). The participant indicated the frequency with which 9 common contact lens-related ocular surface dryness symptoms were experienced over the previous week. Each symptom was rated on a 5-point scale (1=never, 5=constantly). Both eyes contributed to the mean. A more negative change number indicates a greater perceived improvement, namely, lessening of the symptom.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

Impact of a Novel Silicone Hydrogel in Reducing Contact Lens-Related Dryness Symptoms in Existing Contact Lens Wearers

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jul 10, 2012
Registry last updated
Jan 14, 2014

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.

Published trials that share one or more normalized conditions with this study.