Clinical Evaluation of a Silicone Hydrogel Lens
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|ClinicalTrials.gov Identifier: NCT01016132|
Recruitment Status : Completed
First Posted : November 18, 2009
Results First Posted : January 12, 2011
Last Update Posted : June 29, 2012
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
The purpose of this study is to assess the performance of an investigational contact lens among contact lens wearers.
|Condition or disease||Intervention/treatment|
|Myopia||Device: lotrafilcon A contact lens|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||152 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Investigator)|
|Study Start Date :||October 2009|
|Primary Completion Date :||December 2009|
|Study Completion Date :||December 2009|
Device: lotrafilcon A contact lens
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 Measures :
- Overall Preference [ Time Frame: 4 weeks of wear ]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.
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