Back to resultsA Prospective Study of Two Daily Disposable Contact Lenses
Primary Purpose
Myopia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Delefilcon A contact lenses
Etafilcon A contact lenses
Sponsored by
About this trial
This is an interventional treatment trial for Myopia focused on measuring myopia, contact lenses, dry eyes, comfort, replacement
Eligibility Criteria
Inclusion Criteria:
- Be of legal age of consent and sign written Informed Consent Document and HIPAA form.
- Currently wearing soft contact lenses and identified as having contact lens-related dryness symptoms based upon responses to the Contact Lens Dry Eye Questionnaire.
- Wearing either daily disposable contact lenses or bi-weekly/monthly replacement contact lenses, daily wear use only (no extended wear use).
- Able to achieve distance visual acuity of at least 20/25 in each eye with study lenses in the available parameters, -0.50D to -6.00D.
- Willing to wear study lenses for at least 8 hours/day and at least 5 days/week.
- Willing and able to follow instructions and maintain the appointment schedule.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Neophyte or current wearer of DAILIES TOTAL1® or 1-DAY ACUVUE® MOIST™ contact lenses.
- Requires monovision or presbyopic correction.
- Any systemic or ocular disease or disorder complicating factors or structural abnormality that would negatively affect the conduct or outcome of the study.
- Recent (within 7 days of enrollment) or current ocular infection, active ocular inflammation, glaucoma or preauricular lymphadenopathy.
- Clinically significant lash or lid abnormality.
- Systemic disease that, in the investigator's best judgment, would prohibit or confound safe contact lens wear.
- History of ocular surgery/trauma within the last 6 months.
- Topical or systemic antibiotics use within 7 days of enrollment.
- Other protocol-defined exclusion criteria may apply.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
DT1
1DAVM
Arm Description
Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks
Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks
Outcomes
Primary Outcome Measures
Mean Change From Baseline in Subjective Contact Lens-related Dryness Symptoms at Week 4 as Assessed by the CLDEQ
Contact lens symptoms were evaluated using the Contact Lens and Dry Eye Questionnaire (CLDEQ). The participant indicated the frequency with which 9 common contact lens-related ocular surface dryness symptoms were experienced over the previous week. Each symptom was rated on a 5-point scale (1=never, 5=constantly). Both eyes contributed to the mean. A more negative change number indicates a greater perceived improvement, namely, lessening of the symptom.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01636986
Brief Title
A Prospective Study of Two Daily Disposable Contact Lenses
Official Title
Impact of a Novel Silicone Hydrogel in Reducing Contact Lens-Related Dryness Symptoms in Existing Contact Lens Wearers
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study was to evaluate the performance of a novel silicone hydrogel contact lens, DAILIES TOTAL1® (DT1) compared to the standard hydrogel material in 1-DAY ACUVUE® MOIST® (1DAVM) contact lens in contact lens wearers identified as having contact lens-related dryness symptoms.
Detailed Description
Three study visits occurred over the course of 28 ± 3 days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
Keywords
myopia, contact lenses, dry eyes, comfort, replacement
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DT1
Arm Type
Experimental
Arm Description
Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks
Arm Title
1DAVM
Arm Type
Active Comparator
Arm Description
Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks
Intervention Type
Device
Intervention Name(s)
Delefilcon A contact lenses
Other Intervention Name(s)
DAILIES TOTAL1®
Intervention Description
Silicone hydrogel contact lenses for daily wear, daily disposable use
Intervention Type
Device
Intervention Name(s)
Etafilcon A contact lenses
Other Intervention Name(s)
1-DAY ACUVUE® MOIST™
Intervention Description
Hydrogel contact lenses for daily wear, daily disposable use
Primary Outcome Measure Information:
Title
Mean Change From Baseline in Subjective Contact Lens-related Dryness Symptoms at Week 4 as Assessed by the CLDEQ
Description
Contact lens symptoms were evaluated using the Contact Lens and Dry Eye Questionnaire (CLDEQ). The participant indicated the frequency with which 9 common contact lens-related ocular surface dryness symptoms were experienced over the previous week. Each symptom was rated on a 5-point scale (1=never, 5=constantly). Both eyes contributed to the mean. A more negative change number indicates a greater perceived improvement, namely, lessening of the symptom.
Time Frame
Day 0, Week 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
43 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Be of legal age of consent and sign written Informed Consent Document and HIPAA form.
Currently wearing soft contact lenses and identified as having contact lens-related dryness symptoms based upon responses to the Contact Lens Dry Eye Questionnaire.
Wearing either daily disposable contact lenses or bi-weekly/monthly replacement contact lenses, daily wear use only (no extended wear use).
Able to achieve distance visual acuity of at least 20/25 in each eye with study lenses in the available parameters, -0.50D to -6.00D.
Willing to wear study lenses for at least 8 hours/day and at least 5 days/week.
Willing and able to follow instructions and maintain the appointment schedule.
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
Neophyte or current wearer of DAILIES TOTAL1® or 1-DAY ACUVUE® MOIST™ contact lenses.
Requires monovision or presbyopic correction.
Any systemic or ocular disease or disorder complicating factors or structural abnormality that would negatively affect the conduct or outcome of the study.
Recent (within 7 days of enrollment) or current ocular infection, active ocular inflammation, glaucoma or preauricular lymphadenopathy.
Clinically significant lash or lid abnormality.
Systemic disease that, in the investigator's best judgment, would prohibit or confound safe contact lens wear.
History of ocular surgery/trauma within the last 6 months.
Topical or systemic antibiotics use within 7 days of enrollment.
Other protocol-defined exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jami Kern, Ph.D.
Organizational Affiliation
Alcon Research
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
A Prospective Study of Two Daily Disposable Contact Lenses
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