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

This study has been completed.
Information provided by (Responsible Party):
Alcon Research Identifier:
First received: June 6, 2012
Last updated: September 27, 2013
Last verified: September 2013
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 Intervention
Dry Eye Syndrome Myopia Device: Nelfilcon A contact lenses

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • 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.

Enrollment: 88
Study Start Date: June 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01614600

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

Responsible Party: Alcon Research Identifier: NCT01614600     History of Changes
Other Study ID Numbers: A00849
Study First Received: June 6, 2012
Results First Received: September 27, 2013
Last Updated: September 27, 2013

Keywords provided by Alcon Research:
contact lens
dry eye syndrome
daily disposable

Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Refractive Errors
Eye Diseases
Lacrimal Apparatus Diseases
Conjunctival Diseases
Corneal Diseases processed this record on August 18, 2017