Clinical comparison of silicone hydrogel monthly lenses (CLL541-P001)
Research type
Research Study
Full title
One-month clinical comparison of silicone hydrogel monthly lenses in high lipid depositors
IRAS ID
228285
Contact name
Kishan Patel
Contact email
Sponsor organisation
Alcon Research Ltd. (Alcon Laboratories Inc.)
Duration of Study in the UK
0 years, 5 months, 23 days
Research summary
Silicone hydrogel contact lenses provide better oxygen transmissibility, but have been associated with increased lipid deposition and in some cases with a reduced wettability. Alcon implemented two innovative technologies for deposit protection and longer-lasting lens surface moisture. AIR OPTIX plus HydraGlyde monthly replacement contact lenses bring together these two technologies.
This study has been designed to compare the performance of AIR OPTIX plus HydraGlyde and ACUVUE VITA to demonstrate less lipid uptake by AIR OPTIX plus HydraGlyde after 30 days of wear.
Up to 140 monthly replacement contact lens wearers will be enrolled and screened to identify if they are high lipid depositors. The selection will be based upon the amount of tear lipid that the screening contact lens (PureVision 2) has taken up after 10 hours of wear. Approximately 78 participants will progress to the investigational phase when they will wear the two study contact lenses. Each study contact lens will be worn for a period of 30 (-0/+3) days; the order of us of the contact lenses will be randomized.
All participants will attend the first two visits of the screening phase and those who progress to the investigational phase will attend an additional four visits. During the investigational phase the participants will also complete remote questionnaires by responding to text messages on a weekly basis.REC name
London - West London & GTAC Research Ethics Committee
REC reference
17/LO/1027
Date of REC Opinion
30 Jun 2017
REC opinion
Unfavourable Opinion