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Clinical Evaluation of a Daily Disposable Contact Lens in Symptomatic Weekly/Monthly Lens Wearers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01614600
Recruitment Status : Completed
First Posted : June 8, 2012
Results First Posted : December 4, 2013
Last Update Posted : December 4, 2013
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
The purpose of this study was to evaluate the reduction of contact lens-related dryness symptoms when symptomatic weekly/monthly contact lens wearers were switched to DAILIES® AquaComfort Plus® lenses for a two-week period using composite scores on the Contact Lens Dry Eye Questionnaire (CLDEQ).

Condition or disease Intervention/treatment Phase
Dry Eye Syndrome Myopia Device: Nelfilcon A contact lenses Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of a Daily Disposable Contact Lens in Symptomatic Weekly/Monthly Lens Wearers
Study Start Date : June 2012
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
Experimental: DAILIES® AquaComfort Plus®
Nelfilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 2 weeks
Device: Nelfilcon A contact lenses
Commercially marketed hydrogel contact lenses for daily wear, daily disposable use
Other Name: DAILIES® AquaComfort Plus®

Primary Outcome Measures :
  1. Mean Change From Baseline in Contact Lens-Related Dryness Symptoms at Week 1 and Week 2 [ Time Frame: Baseline, Week 1, Week 2 ]
    Contact lens symptoms were evaluated using the Contact Lens Dry Eye Questionnaire (CLDEQ). Subjects rated 8 common contact lens-related ocular surface dryness symptoms at Baseline, Week 1, and Week 2 using a 5-point scale (1=never or not at all intense, 5=constantly or very intense). A scoring algorithm was used to calculate a composite score for each visit for all symptoms (-6.5 to 10). A higher composite score would indicate more contact lens related dry eye and a lower score, less contact lens related dry eye.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Currently wearing weekly/monthly, silicone hydrogel or traditional hydrogel soft contact lenses at least 8 hours per day and 5 days a week during the past 6 months.
  • Identified as symptomatic using a baseline screening questionnaire.
  • Requires vision correction in both eyes with a contact lens prescription as follows: sphere powers between -0.50 and -10.00 diopter (D) and cylinder powers </= 0.75D and no ADD correction.
  • Able to achieve visual acuity (VA) of at least 6/7.5 in each eye with study lenses in the available parameters.
  • Willing to wear study lenses for at least 8 hours/day and at least 5 days/week and discard the lenses at the end of the day and replace lenses every day with a new fresh pair.
  • Willing and able to follow instructions and maintain the appointment schedule.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Neophytes and current wearers of daily disposable contact lenses.
  • Requires monovision correction.
  • Any systemic or ocular disease or disorder (refractive disorder allowed) complicating factors or structural abnormality that would negatively affect the conduct or outcome of the study.
  • A history of ocular surgery/trauma within the last 6 months.
  • Unwilling to discontinue mechanical eyelid therapy or eyelid scrubs within 14 days of enrollment and continuing during the study.
  • Participation in any other ophthalmic drug or device clinical trial within 30 days of enrollment.
  • Other protocol-defined exclusion criteria may apply.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01614600

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

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Responsible Party: Alcon Research Identifier: NCT01614600    
Other Study ID Numbers: A00849
First Posted: June 8, 2012    Key Record Dates
Results First Posted: December 4, 2013
Last Update Posted: December 4, 2013
Last Verified: September 2013
Keywords provided by Alcon Research:
contact lens
dry eye syndrome
daily disposable
Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Conjunctival Diseases
Eye Diseases
Corneal Diseases
Lacrimal Apparatus Diseases
Refractive Errors