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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01614600
First received: June 6, 2012
Last updated: November 8, 2012
Last verified: November 2012
History of Changes
  Purpose

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


Condition Intervention
Dry Eye
Myopia
 Device: nelfilcon A contact lens (DAILIES® AquaComfort Plus®)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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:

MedlinePlus related topics: Eye Wear
U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Mean change from baseline in contact lens-related dryness symptoms at 30 days [ Time Frame: Baseline, 30 days ] [ Designated as safety issue: No ]
    Contact lens symptoms will be measured using the Contact Lens Dry Eye Questionnaire (CLDEQ). Subjects will rate their frequency and severity of eight common contact lens-related symptoms to compile an average aggregate score.


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: DACP
Contact lenses per participant's habitual prescription worn bilaterally on a daily wear, daily disposable basis for 30 days.
 Device: nelfilcon A contact lens (DAILIES® AquaComfort Plus®)
Commercially marketed hydrogel contact lens for daily wear, daily disposable use
Other Name: DAILIES® AquaComfort Plus®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 Rx as follows: sphere powers between -0.50 and -10.00 D and cylinder powers </= 0.75D and no ADD correction.
  • Able to achieve 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01614600

Locations
United States, Texas
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Director, Global Medical Affairs Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01614600     History of Changes
Other Study ID Numbers: A00849
Study First Received: June 6, 2012
Last Updated: November 8, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Myopia
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
 Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Refractive Errors

ClinicalTrials.gov processed this record on May 23, 2013