Back to resultsProspective Study of an Investigational Daily Disposable Contact Lens
Primary Purpose
Myopia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
delefilcon A contact lens
narafilcon B contact lens
Sponsored by
About this trial
This is an interventional treatment trial for Myopia
Eligibility Criteria
Inclusion Criteria:
- Subjects with normal eyes who are not using any 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 at least 5 days per week.
- Willing and able to wear spherical contact lenses within the available range of powers of -1.00 diopter(D) to -6.00D in 0.25D steps.
- Best spectacle-corrected visual acuity greater than or equal to 20/25.
- Manifest cylinder less than or equal to 0.75D.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- 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.
- History of pathologically dry eye.
- Eye injury within twelve weeks immediately prior to enrollment for this trial.
- Currently enrolled in any clinical trial.
- Participation in a contact lens or contact lens care product clinical trial within the previous 30 days.
- Other protocol-defined exclusion criteria may apply.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
delefilcon A
narafilcon B
Arm Description
Investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
Commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
Outcomes
Primary Outcome Measures
Corrected Distance Monocular Visual Measurement in Normal Illumination Reported as Visual Acuity
Each eye tested individually while reading a chart distant to the participant in normal lighting. Visual acuity was measured using a Snellen chart, with 20/20 Snellen acuity considered normal distance-eyesight. Visual acuity is reported as the number of eyes achieving 20/20 Snellen acuity or better.
Secondary Outcome Measures
Overall Vision
As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall vision was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.
Overall Comfort
As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall comfort 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 3 months of wear time. Overall handling was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01295905
Brief Title
Prospective Study of an Investigational Daily Disposable Contact Lens
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CIBA VISION
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to evaluate the performance of an investigational 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
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
delefilcon A
Arm Type
Experimental
Arm Description
Investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
Arm Title
narafilcon B
Arm Type
Active Comparator
Arm Description
Commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
Intervention Type
Device
Intervention Name(s)
delefilcon A contact lens
Intervention Description
Investigational silicone hydrogel, single vision soft contact lens
Intervention Type
Device
Intervention Name(s)
narafilcon B contact lens
Intervention Description
Commercially marketed silicone hydrogel, single vision soft contact lens
Primary Outcome Measure Information:
Title
Corrected Distance Monocular Visual Measurement in Normal Illumination Reported as Visual Acuity
Description
Each eye tested individually while reading a chart distant to the participant in normal lighting. Visual acuity was measured using a Snellen chart, with 20/20 Snellen acuity considered normal distance-eyesight. Visual acuity is reported as the number of eyes achieving 20/20 Snellen acuity or better.
Time Frame
3 months of wear, lenses replaced daily
Secondary Outcome Measure Information:
Title
Overall Vision
Description
As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall vision was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.
Time Frame
3 months of wear, lenses replaced daily
Title
Overall Comfort
Description
As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months 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
3 months of wear, lenses replaced daily
Title
Overall Handling
Description
As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall handling was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.
Time Frame
3 months of wear, lenses replaced daily
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects with normal eyes who are not using any 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 at least 5 days per week.
Willing and able to wear spherical contact lenses within the available range of powers of -1.00 diopter(D) to -6.00D in 0.25D steps.
Best spectacle-corrected visual acuity greater than or equal to 20/25.
Manifest cylinder less than or equal to 0.75D.
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
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.
History of pathologically dry eye.
Eye injury within twelve weeks immediately prior to enrollment for this trial.
Currently enrolled in any clinical trial.
Participation in a contact lens or contact lens care product clinical trial within the previous 30 days.
Other protocol-defined exclusion criteria may apply.
12. IPD Sharing Statement
Learn more about this trial
Prospective Study of an Investigational Daily Disposable Contact Lens
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