Back to resultsClinical Evaluation of an Investigational Soft Contact Lens
Primary Purpose
Myopia
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Delefilcon A contact lens
Lotrafilcon B contact lens (O2 OPTIX, AIR OPTIX)
Nelfilcon A contact lens (DAILIES AquaComfort Plus)
Narafilcon A contact lens (1-DAY ACUVUE TRUEYE)
Sponsored by
About this trial
This is an interventional treatment trial for Myopia
Eligibility Criteria
Inclusion Criteria:
- Germany: Be of legal age.
- USA: Be of legal age or, if under legal age, have written consent of parent/guardian to participate and sign informed assent.
- Sign Informed Consent.
- Wear soft contact lenses for at least 3 months prior to the study.
- Wear soft contact lenses on a daily disposable basis, daily wear basis, or occasional extended wear basis.
- Other protocol-defined inclusion/exclusion criteria may apply.
Exclusion Criteria:
- Eye injury or surgery within twelve weeks prior to enrollment.
- Pre-existing ocular irritation that would preclude contact lens fitting.
- Currently enrolled in any clinical trial.
- Regularly wear contact lenses on an extended/overnight basis.
- Germany: pregnant or lactating.
- Other protocol-defined inclusion/exclusion criteria may apply.
Sites / Locations
- CIBA VISION Research Clinic
- CIBA VISION Research Clinic
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Active Comparator
Active Comparator
Arm Label
Delefilcon A
Lotrafilcon B
Nelfilcon A
Narafilcon A
Arm Description
Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
Outcomes
Primary Outcome Measures
Overall Comfort
Overall comfort was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall comfort was measured on a 10-point scale, with 1 being poor and 10 being excellent.
Vision Quality During the Day
Vision quality during the day was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Vision quality during the day was measured on a 10-point scale, with 1 being poor and 10 being excellent.
Overall Handling
Overall handling was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall handling was measured on a 10-point scale, with 1 being poor and 10 being excellent.
Dryness Throughout the Day
Dryness throughout the day was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Dryness throughout the day was measured on a 10-point scale, with 1 being very dry and 10 being not dry.
Average Daily Wear Time
Average daily wear time (hours) was reported by the participant as a single, retrospective evaluation of 4 weeks of wear.
Secondary Outcome Measures
Lens Fit
Lens fit was assessed by the investigator for each eye using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit was graded on a 5-point scale, with 2=unacceptable loose, 1=acceptable loose, 0=optimal, -1=acceptable tight, and -2=unacceptable tight.
Corrected Visual Acuity
Corrected visual acuity was tested for each eye while the participant read distant charts in normal lighting. Corrected visual acuity was measured with a Snellen chart, which was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal distance eyesight. Positive logMAR values indicate poorer vision, and negative values denote better visual acuity.
Overall Satisfaction
Overall satisfaction was recorded on a 5-point Likert scale as a single, retrospective evaluation of 4 weeks of wear. The following scale was used: 2=very satisfied, 1=somewhat satisfied, 0=neither, -1=somewhat dissatisfied, and -2=very dissatisfied.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01254747
Brief Title
Clinical Evaluation of an Investigational Soft Contact Lens
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (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 4-week dispensing trial is to evaluate and compare an investigational soft contact lens worn on a daily disposable basis with three other soft contact lenses also worn on a daily disposable basis.
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
130 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Delefilcon A
Arm Type
Experimental
Arm Description
Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
Arm Title
Lotrafilcon B
Arm Type
Active Comparator
Arm Description
Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
Arm Title
Nelfilcon A
Arm Type
Active Comparator
Arm Description
Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
Arm Title
Narafilcon A
Arm Type
Active Comparator
Arm Description
Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
Intervention Type
Device
Intervention Name(s)
Delefilcon A contact lens
Other Intervention Name(s)
DAILIES TOTAL1®
Intervention Description
Investigational silicone hydrogel, single vision contact lens for daily wear, daily disposable use
Intervention Type
Device
Intervention Name(s)
Lotrafilcon B contact lens (O2 OPTIX, AIR OPTIX)
Other Intervention Name(s)
O2 OPTIX®, AIR OPTIX®
Intervention Description
Commercially marketed silicone hydrogel, single vision contact lens for daily wear, daily disposable use
Intervention Type
Device
Intervention Name(s)
Nelfilcon A contact lens (DAILIES AquaComfort Plus)
Other Intervention Name(s)
DAILIES® AquaComfort Plus®
Intervention Description
Commercially marketed hydrogel, single vision contact lens for daily wear, daily disposable use
Intervention Type
Device
Intervention Name(s)
Narafilcon A contact lens (1-DAY ACUVUE TRUEYE)
Other Intervention Name(s)
1-DAY ACUVUE® TRUEYE™
Intervention Description
Commercially marketed (Europe) silicone hydrogel, single vision contact lens for daily wear, daily disposable use
Primary Outcome Measure Information:
Title
Overall Comfort
Description
Overall comfort was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall comfort was measured on a 10-point scale, with 1 being poor and 10 being excellent.
Time Frame
4 weeks
Title
Vision Quality During the Day
Description
Vision quality during the day was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Vision quality during the day was measured on a 10-point scale, with 1 being poor and 10 being excellent.
Time Frame
4 weeks
Title
Overall Handling
Description
Overall handling was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall handling was measured on a 10-point scale, with 1 being poor and 10 being excellent.
Time Frame
4 weeks
Title
Dryness Throughout the Day
Description
Dryness throughout the day was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Dryness throughout the day was measured on a 10-point scale, with 1 being very dry and 10 being not dry.
Time Frame
4 weeks
Title
Average Daily Wear Time
Description
Average daily wear time (hours) was reported by the participant as a single, retrospective evaluation of 4 weeks of wear.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Lens Fit
Description
Lens fit was assessed by the investigator for each eye using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit was graded on a 5-point scale, with 2=unacceptable loose, 1=acceptable loose, 0=optimal, -1=acceptable tight, and -2=unacceptable tight.
Time Frame
4 weeks
Title
Corrected Visual Acuity
Description
Corrected visual acuity was tested for each eye while the participant read distant charts in normal lighting. Corrected visual acuity was measured with a Snellen chart, which was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal distance eyesight. Positive logMAR values indicate poorer vision, and negative values denote better visual acuity.
Time Frame
4 weeks
Title
Overall Satisfaction
Description
Overall satisfaction was recorded on a 5-point Likert scale as a single, retrospective evaluation of 4 weeks of wear. The following scale was used: 2=very satisfied, 1=somewhat satisfied, 0=neither, -1=somewhat dissatisfied, and -2=very dissatisfied.
Time Frame
4 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Germany: Be of legal age.
USA: Be of legal age or, if under legal age, have written consent of parent/guardian to participate and sign informed assent.
Sign Informed Consent.
Wear soft contact lenses for at least 3 months prior to the study.
Wear soft contact lenses on a daily disposable basis, daily wear basis, or occasional extended wear basis.
Other protocol-defined inclusion/exclusion criteria may apply.
Exclusion Criteria:
Eye injury or surgery within twelve weeks prior to enrollment.
Pre-existing ocular irritation that would preclude contact lens fitting.
Currently enrolled in any clinical trial.
Regularly wear contact lenses on an extended/overnight basis.
Germany: pregnant or lactating.
Other protocol-defined inclusion/exclusion criteria may apply.
Facility Information:
Facility Name
CIBA VISION Research Clinic
City
Duluth
State/Province
Georgia
ZIP/Postal Code
30097
Country
United States
Facility Name
CIBA VISION Research Clinic
City
Grosswallstadt
ZIP/Postal Code
63868
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Clinical Evaluation of an Investigational Soft Contact Lens
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