Back to resultsSubjective Evaluation of a Commercially Marketed Contact Lens Amongst a Subset of the Contact Lens Wearing Population
Primary Purpose
Myopia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lotrafilcon B contact lens
Habitual contact lens
Sponsored by
About this trial
This is an interventional treatment trial for Myopia
Eligibility Criteria
Inclusion Criteria:
- Habitual spherical soft contact lens wearer who wears a contact lens with a recommended replacement schedule of 2 weeks or monthly.
- Wears lenses at least 5 days per week and at least 12 hours per day.
- Removes contact lenses daily or, if prescribed by their regular eye care practitioner, sleeps overnight in contact lenses no more than 6 consecutive nights.
- Reports 2 or fewer common lens-related symptoms with current contact lenses with a frequency of "frequently" or "always".
- Able to achieve distance visual acuity of at least 20/40 in each eye at the dispense of each pair of study lenses.
- Has acceptable or optimal fit for each eye at the dispense of each pair of study lenses.
- 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.
- Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.
- Currently sleeping in contact lenses for more than 6 consecutive nights.
- Currently wearing daily disposable contact lenses and certain protocol-specified lens brands.
- Other protocol-defined inclusion/exclusion criteria may apply.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Lotrafilcon B / Habitual
Habitual / Lotrafilcon B
Arm Description
Lotrafilcon B contact lenses worn first, with habitual contact lenses worn second. Both products worn bilaterally as often as is typical for habitual lenses, and in the same modality as is typical for habitual lenses, as prescribed by regular eye care practitioner, with extended wear not to exceed 6 nights.
Habitual contact lenses worn first, with lotrafilcon B lenses worn second. Both products worn bilaterally as often as is typical for habitual lenses, and in the same modality as is typical for habitual lenses, as prescribed by regular eye care practitioner, with extended wear not to exceed 6 nights.
Outcomes
Primary Outcome Measures
Comfort Upon Insertion
Comfort upon insertion, as interpreted by the participant, was recorded on a questionnaire by the participant using a 10-point scale, with 1 being poor and 10 being excellent. Comfort upon insertion was assessed as a single, retrospective evaluation of 4-weeks' wear time.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01007916
Brief Title
Subjective Evaluation of a Commercially Marketed Contact Lens Amongst a Subset of the Contact Lens Wearing Population
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 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 study is to compare the performance of commercially marketed contact lenses to habitual contact lenses in a selected segment of the contact lens wearing population.
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
Participant
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lotrafilcon B / Habitual
Arm Type
Other
Arm Description
Lotrafilcon B contact lenses worn first, with habitual contact lenses worn second. Both products worn bilaterally as often as is typical for habitual lenses, and in the same modality as is typical for habitual lenses, as prescribed by regular eye care practitioner, with extended wear not to exceed 6 nights.
Arm Title
Habitual / Lotrafilcon B
Arm Type
Other
Arm Description
Habitual contact lenses worn first, with lotrafilcon B lenses worn second. Both products worn bilaterally as often as is typical for habitual lenses, and in the same modality as is typical for habitual lenses, as prescribed by regular eye care practitioner, with extended wear not to exceed 6 nights.
Intervention Type
Device
Intervention Name(s)
Lotrafilcon B contact lens
Intervention Description
Commercially marketed, silicone hydrogel, spherical contact lens having a recommended replacement schedule of monthly.
Intervention Type
Device
Intervention Name(s)
Habitual contact lens
Intervention Description
Habitual soft spherical contact lens having a recommended replacement schedule of 2 weeks or monthly.
Primary Outcome Measure Information:
Title
Comfort Upon Insertion
Description
Comfort upon insertion, as interpreted by the participant, was recorded on a questionnaire by the participant using a 10-point scale, with 1 being poor and 10 being excellent. Comfort upon insertion was assessed as a single, retrospective evaluation of 4-weeks' wear time.
Time Frame
4 weeks of wear
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Habitual spherical soft contact lens wearer who wears a contact lens with a recommended replacement schedule of 2 weeks or monthly.
Wears lenses at least 5 days per week and at least 12 hours per day.
Removes contact lenses daily or, if prescribed by their regular eye care practitioner, sleeps overnight in contact lenses no more than 6 consecutive nights.
Reports 2 or fewer common lens-related symptoms with current contact lenses with a frequency of "frequently" or "always".
Able to achieve distance visual acuity of at least 20/40 in each eye at the dispense of each pair of study lenses.
Has acceptable or optimal fit for each eye at the dispense of each pair of study lenses.
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.
Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.
Currently sleeping in contact lenses for more than 6 consecutive nights.
Currently wearing daily disposable contact lenses and certain protocol-specified lens brands.
Other protocol-defined inclusion/exclusion criteria may apply.
12. IPD Sharing Statement
Learn more about this trial
Subjective Evaluation of a Commercially Marketed Contact Lens Amongst a Subset of the Contact Lens Wearing Population
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