Back to resultsClinical Evaluation of a Silicone Hydrogel Lens
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:
- Currently wearing lotrafilcon A lenses in both eyes for a minimum of 5 days per week, 8 hours per day, for 3 months.
- Removes contact lenses daily or sleeps overnight in contact lenses (up to 30 consecutive nights) as prescribed by regular eye care practitioner.
- Able to achieve distance visual acuity of at least 20/40 in each eye with study lenses.
- Other protocol inclusion/exclusion criteria may apply.
Exclusion Criteria:
- Eye injury or surgery within 12 months prior to enrollment.
- Currently enrolled in any clinical trial.
- History of corneal refractive surgery.
- Other protocol inclusion/exclusion criteria may apply.
Sites / Locations
Outcomes
Primary Outcome Measures
Overall Preference
Overall preference when comparing study lenses to "habitual" lenses, as interpreted by the participant and reported on a questionnaire as a single, retrospective evaluation of four weeks' wear time. Overall preference was measured on a 5-point Likert scale as follows: Strongly Prefer Study Lenses; Somewhat Prefer Study Lenses; No Preference; Somewhat Prefer "Habitual" Lenses; Strongly Prefer "Habitual" Lenses.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01016132
Brief Title
Clinical Evaluation of a Silicone Hydrogel Lens
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 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 study is to assess the performance of an investigational contact lens among contact lens wearers.
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
ParticipantInvestigator
Allocation
N/A
Enrollment
152 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
lotrafilcon A contact lens
Intervention Description
Investigational silicone hydrogel, single-vision, soft contact lens worn for four weeks at least as often as and on the same basis as participant's habitual lenses, as prescribed by participant's eye care practitioner -- ie., on a daily wear, flex wear, or extended wear basis.
Primary Outcome Measure Information:
Title
Overall Preference
Description
Overall preference when comparing study lenses to "habitual" lenses, as interpreted by the participant and reported on a questionnaire as a single, retrospective evaluation of four weeks' wear time. Overall preference was measured on a 5-point Likert scale as follows: Strongly Prefer Study Lenses; Somewhat Prefer Study Lenses; No Preference; Somewhat Prefer "Habitual" Lenses; Strongly Prefer "Habitual" Lenses.
Time Frame
4 weeks of wear
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Currently wearing lotrafilcon A lenses in both eyes for a minimum of 5 days per week, 8 hours per day, for 3 months.
Removes contact lenses daily or sleeps overnight in contact lenses (up to 30 consecutive nights) as prescribed by regular eye care practitioner.
Able to achieve distance visual acuity of at least 20/40 in each eye with study lenses.
Other protocol inclusion/exclusion criteria may apply.
Exclusion Criteria:
Eye injury or surgery within 12 months prior to enrollment.
Currently enrolled in any clinical trial.
History of corneal refractive surgery.
Other protocol inclusion/exclusion criteria may apply.
12. IPD Sharing Statement
Learn more about this trial
Clinical Evaluation of a Silicone Hydrogel Lens
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