Back to resultsClinical Evaluation of a Daily Disposable Contact Lens in Symptomatic Weekly/Monthly Lens Wearers
Primary Purpose
Dry Eye Syndrome, Myopia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nelfilcon A contact lenses
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye Syndrome focused on measuring contact lens, dry eye syndrome, symptomatic, daily disposable, myopia
Eligibility 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 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
DAILIES® AquaComfort Plus®
Arm Description
Nelfilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 2 weeks
Outcomes
Primary Outcome Measures
Mean Change From Baseline in Contact Lens-Related Dryness Symptoms at Week 1 and 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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01614600
Brief Title
Clinical Evaluation of a Daily Disposable Contact Lens in Symptomatic Weekly/Monthly Lens Wearers
Official Title
Clinical Evaluation of a Daily Disposable Contact Lens in Symptomatic Weekly/Monthly Lens Wearers
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndrome, Myopia
Keywords
contact lens, dry eye syndrome, symptomatic, daily disposable, myopia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
88 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DAILIES® AquaComfort Plus®
Arm Type
Experimental
Arm Description
Nelfilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 2 weeks
Intervention Type
Device
Intervention Name(s)
Nelfilcon A contact lenses
Other Intervention Name(s)
DAILIES® AquaComfort Plus®
Intervention Description
Commercially marketed hydrogel contact lenses for daily wear, daily disposable use
Primary Outcome Measure Information:
Title
Mean Change From Baseline in Contact Lens-Related Dryness Symptoms at Week 1 and Week 2
Description
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.
Time Frame
Baseline, Week 1, Week 2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jami Kern, MBA, PhD
Organizational Affiliation
Alcon Research
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Clinical Evaluation of a Daily Disposable Contact Lens in Symptomatic Weekly/Monthly Lens Wearers
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