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

June 6, 2012
November 8, 2012
June 2012
September 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01614600 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Clinical Evaluation of a Daily Disposable Contact Lens in Symptomatic Weekly/Monthly Lens Wearers
Clinical Evaluation of a Daily Disposable Contact Lens in Symptomatic Weekly/Monthly Lens Wearers

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.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Dry Eye
  • Myopia
Device: nelfilcon A contact lens (DAILIES® AquaComfort Plus®)
Commercially marketed hydrogel contact lens for daily wear, daily disposable use
Other Name: DAILIES® AquaComfort Plus®
Experimental: DACP
Contact lenses per participant's habitual prescription worn bilaterally on a daily wear, daily disposable basis for 30 days.
Intervention: Device: nelfilcon A contact lens (DAILIES® AquaComfort Plus®)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
88
September 2012
September 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01614600
A00849
Yes
Alcon Research
Alcon Research
Not Provided
Study Director: Director, Global Medical Affairs Alcon Research
Alcon Research
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP