A Prospective Study of Two Daily Disposable Contact Lenses

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01636986
First received: July 6, 2012
Last updated: November 25, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Myopia
Device: Delefilcon A contact lenses
Device: Etafilcon A contact lenses

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Impact of a Novel Silicone Hydrogel in Reducing Contact Lens-Related Dryness Symptoms in Existing Contact Lens Wearers

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 62
Study Start Date: July 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DT1
Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks
Device: Delefilcon A contact lenses
Silicone hydrogel contact lenses for daily wear, daily disposable use
Other Name: DAILIES TOTAL1®
Active Comparator: 1DAVM
Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks
Device: Etafilcon A contact lenses
Hydrogel contact lenses for daily wear, daily disposable use
Other Name: 1-DAY ACUVUE® MOIST™

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 43 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01636986

Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Jami Kern, Ph.D. Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01636986     History of Changes
Other Study ID Numbers: A00930
Study First Received: July 6, 2012
Results First Received: November 25, 2013
Last Updated: November 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Alcon Research:
myopia
contact lenses
dry eyes
comfort
replacement

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on April 14, 2014