Assessment of Lotrafilcon A Contact Lenses
This study has been completed.
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
First received: August 18, 2010
Last updated: June 26, 2012
Last verified: December 2011
The purpose of this 3-month study is to evaluate subjective responses to an upgraded contact lens.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Assessment of Lotrafilcon A Contact Lenses|
Resource links provided by NLM:
Further study details as provided by Alcon Research:
Primary Outcome Measures:
- Overall Comfort [ Time Frame: 3 months of wear, replacing lenses monthly ] [ Designated as safety issue: No ]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 [ Time Frame: 3 months of wear, replacing lenses monthly ] [ Designated as safety issue: No ]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
|Study Start Date:||July 2010|
|Study Completion Date:||December 2010|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
Device: Lotrafilcon A upgrade soft contact lens
Silicone hydrogel contact lens approved for daily wear and extended wear up to 30 consecutive nights.
Contacts and Locations
No Contacts or Locations Provided