Back to resultsEvaluation of Lotrafilcon A Lenses Over a Three Month Period
Primary Purpose
Myopia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lotrafilcon A contact lens
Sponsored by
About this trial
This is an interventional treatment trial for Myopia
Eligibility Criteria
Inclusion Criteria:
- On examination, have ocular findings considered to be "normal" and which would not prevent a subject from safely wearing contact lenses.
- Be willing and able to follow instructions and meet the schedule of follow-up visits as defined in the informed consent.
- 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.
- Other protocol inclusion/exclusion criteria may apply.
Exclusion Criteria:
- Eye injury or surgery within twelve weeks immediately prior to enrollment for this trial.
- Pre-existing ocular irritation that would preclude contact lens fitting.
- Currently enrolled in an ophthalmic clinical trial.
- Evidence of systemic or ocular abnormality, infection or disease likely to affect successful wear of contact lenses or use of their accessory solutions.
- Any use of medications for which contact lens wear would be contraindicated, in the opinion of the investigator.
- History of corneal refractive surgery.
- Other protocol inclusion/exclusion criteria may apply.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lotrafilcon A
Arm Description
Outcomes
Primary Outcome Measures
Comfort After Insertion
Comfort after insertion of contact lens (30 seconds to 1 minute), as interpreted by the subject and reported by the subject as a single, retrospective evaluation of 3-month's wear time. Comfort after insertion was measured on a 10-point scale, with 1 being poor and 10 being excellent.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00931307
Brief Title
Evaluation of Lotrafilcon A Lenses Over a Three Month Period
Official Title
Evaluation of Lotrafilcon A Lenses Over a Three Month Period
Study Type
Interventional
2. Study Status
Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (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 trial is to assess the performance of a Lotrafilcon A contact lens over a 3-month period.
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
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lotrafilcon A
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Lotrafilcon A contact lens
Intervention Description
Silicone hydrogel, spherical, soft contact lens
Primary Outcome Measure Information:
Title
Comfort After Insertion
Description
Comfort after insertion of contact lens (30 seconds to 1 minute), as interpreted by the subject and reported by the subject as a single, retrospective evaluation of 3-month's wear time. Comfort after insertion was measured on a 10-point scale, with 1 being poor and 10 being excellent.
Time Frame
3 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
On examination, have ocular findings considered to be "normal" and which would not prevent a subject from safely wearing contact lenses.
Be willing and able to follow instructions and meet the schedule of follow-up visits as defined in the informed consent.
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.
Other protocol inclusion/exclusion criteria may apply.
Exclusion Criteria:
Eye injury or surgery within twelve weeks immediately prior to enrollment for this trial.
Pre-existing ocular irritation that would preclude contact lens fitting.
Currently enrolled in an ophthalmic clinical trial.
Evidence of systemic or ocular abnormality, infection or disease likely to affect successful wear of contact lenses or use of their accessory solutions.
Any use of medications for which contact lens wear would be contraindicated, in the opinion of the investigator.
History of corneal refractive surgery.
Other protocol inclusion/exclusion criteria may apply.
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Lotrafilcon A Lenses Over a Three Month Period
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