Back to resultsAssessment of Lotrafilcon A Contact Lenses
Primary Purpose
Myopia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lotrafilcon A upgrade soft contact lens
Sponsored by
About this trial
This is an interventional treatment trial for Myopia
Eligibility Criteria
Inclusion Criteria:
- Have normal ocular findings.
- Be able to wear the study lenses in the available powers.
- Currently wear contact lenses for a minimum of 5 days a week, and at least 8 hours a day.
- Wear Night & Day contact lenses.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Require concurrent ocular medication.
- Eye injury or surgery within twelve weeks prior to enrollment.
- Currently enrolled in an ophthalmic clinical trial.
- Any active corneal infection.
- Corneal refractive surgery.
- Wear AIR OPTIX NIGHT & DAY AQUA lenses.
- Other protocol-defined exclusion criteria may apply.
Sites / Locations
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Overall Lens Fit
As assessed by the investigator at study visit using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit was graded by eye 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
NCT01185834
Brief Title
Assessment of Lotrafilcon A Contact Lenses
Official Title
Assessment of Lotrafilcon A Contact Lenses
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
July 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
5. Study Description
Brief Summary
The purpose of this 3-month study is to evaluate subjective responses to an upgraded 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
Single Group Assignment
Masking
Participant
Allocation
N/A
Enrollment
118 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Lotrafilcon A upgrade soft contact lens
Intervention Description
Silicone hydrogel contact lens approved for daily wear and extended wear up to 30 consecutive nights.
Primary Outcome Measure Information:
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, replacing lenses monthly
Secondary Outcome Measure Information:
Title
Overall Lens Fit
Description
As assessed by the investigator at study visit using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit was graded by eye on a 5-point scale, with 2=unacceptably loose, 1=acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight
Time Frame
3 months of wear, replacing lenses monthly
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have normal ocular findings.
Be able to wear the study lenses in the available powers.
Currently wear contact lenses for a minimum of 5 days a week, and at least 8 hours a day.
Wear Night & Day contact lenses.
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
Require concurrent ocular medication.
Eye injury or surgery within twelve weeks prior to enrollment.
Currently enrolled in an ophthalmic clinical trial.
Any active corneal infection.
Corneal refractive surgery.
Wear AIR OPTIX NIGHT & DAY AQUA lenses.
Other protocol-defined exclusion criteria may apply.
12. IPD Sharing Statement
Learn more about this trial
Assessment of Lotrafilcon A Contact Lenses
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