Back to resultsClinical Comparison of Silicone Hydrogel and HEMA-based Daily Disposable Contact Lenses
Primary Purpose
Myopia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Delefilcon A contact lens
Etafilcon A contact lens
Sponsored by
About this trial
This is an interventional treatment trial for Myopia
Eligibility Criteria
Inclusion Criteria:
- Normal eyes with no use of ocular medications.
- Be of legal age of consent and sign Informed Consent document. If under legal age of consent, legally authorized representative must sign Informed Consent document and subject must sign Assent document.
- Willing and able to wear spherical contact lenses for protocol-specified timeframe within the available range of powers (-1.00 D to -6.00D in 0.25D steps).
- Visual acuity with study lenses 20/25 or better.
- Cylinder less than or equal to 0.75 D.
- Currently wearing daily disposable lenses.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Anterior segment infection, inflammation, or abnormality.
- Any active anterior segment ocular disease that would contraindicate contact lens wear.
- Any use of systemic medications for which contact lens wear could be contraindicated as determined by the investigator.
- History of refractive surgery or irregular cornea.
- Eye injury within twelve weeks immediately prior to enrollment for this trial.
- Currently enrolled in any clinical trial.
- Other protocol-defined exclusion criteria may apply.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Delefilcon A / etafilcon A
Etafilcon A / delefilcon A
Arm Description
Delefilcon A contact lenses worn first, with etafilcon A contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.
Etafilcon A contact lenses worn first, with delefilcon A contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.
Outcomes
Primary Outcome Measures
Corrected Distance Monocular Visual Measurement Reported as Visual Acuity (VA)
As tested for each eye individually while wearing study lenses. VA was measured using a Snellen chart, which was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equated to a logMAR acuity of 0.0 and was considered normal distance eyesight. Positive logMAR values indicated poorer vision, and negative values denoted better visual acuity.
Overall Comfort
As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.
Overall Vision Quality
As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall vision quality was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.
Overall Handling
As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall handling was evaluated binocularly and rated on a 10-point scale, with 1 being difficult and 10 being easy.
Secondary Outcome Measures
Overall Lens Fit
As assessed for each eye individually by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit is reported on a 5-point scale, with 2=unacceptably loose, 1=acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01362907
Brief Title
Clinical Comparison of Silicone Hydrogel and HEMA-based Daily Disposable Contact Lenses
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CIBA VISION
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this trial was to compare the performance of an investigational daily disposable contact lens to a commercially available daily disposable contact lens.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Delefilcon A / etafilcon A
Arm Type
Other
Arm Description
Delefilcon A contact lenses worn first, with etafilcon A contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.
Arm Title
Etafilcon A / delefilcon A
Arm Type
Other
Arm Description
Etafilcon A contact lenses worn first, with delefilcon A contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.
Intervention Type
Device
Intervention Name(s)
Delefilcon A contact lens
Other Intervention Name(s)
DAILIES® Total1®
Intervention Description
Investigational, silicone hydrogel, single vision, soft contact lens for daily disposable wear
Intervention Type
Device
Intervention Name(s)
Etafilcon A contact lens
Other Intervention Name(s)
1-DAY ACUVUE® MOIST™
Intervention Description
Commercially marketed, HEMA-based, single vision, soft contact lens for daily disposable wear
Primary Outcome Measure Information:
Title
Corrected Distance Monocular Visual Measurement Reported as Visual Acuity (VA)
Description
As tested for each eye individually while wearing study lenses. VA was measured using a Snellen chart, which was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equated to a logMAR acuity of 0.0 and was considered normal distance eyesight. Positive logMAR values indicated poorer vision, and negative values denoted better visual acuity.
Time Frame
1 week of wear, replacing lenses daily
Title
Overall Comfort
Description
As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.
Time Frame
1 week of wear, replacing lenses daily
Title
Overall Vision Quality
Description
As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall vision quality was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.
Time Frame
1 week of wear, replacing lenses daily
Title
Overall Handling
Description
As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall handling was evaluated binocularly and rated on a 10-point scale, with 1 being difficult and 10 being easy.
Time Frame
1 week of wear, replacing lenses daily
Secondary Outcome Measure Information:
Title
Overall Lens Fit
Description
As assessed for each eye individually by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit is reported on a 5-point scale, with 2=unacceptably loose, 1=acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight.
Time Frame
1 week of wear, replacing lenses daily
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Normal eyes with no use of ocular medications.
Be of legal age of consent and sign Informed Consent document. If under legal age of consent, legally authorized representative must sign Informed Consent document and subject must sign Assent document.
Willing and able to wear spherical contact lenses for protocol-specified timeframe within the available range of powers (-1.00 D to -6.00D in 0.25D steps).
Visual acuity with study lenses 20/25 or better.
Cylinder less than or equal to 0.75 D.
Currently wearing daily disposable lenses.
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
Anterior segment infection, inflammation, or abnormality.
Any active anterior segment ocular disease that would contraindicate contact lens wear.
Any use of systemic medications for which contact lens wear could be contraindicated as determined by the investigator.
History of refractive surgery or irregular cornea.
Eye injury within twelve weeks immediately prior to enrollment for this trial.
Currently enrolled in any clinical trial.
Other protocol-defined exclusion criteria may apply.
12. IPD Sharing Statement
Learn more about this trial
Clinical Comparison of Silicone Hydrogel and HEMA-based Daily Disposable Contact Lenses
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