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
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: 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 July 31, 2014