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
232494
Contact name
Kishan Patel
Contact email
Sponsor organisation
Alcon Research Ltd. (Alcon Laboratories Inc.)
Duration of Study in the UK
0 years, 6 months, 1 days
Research summary
Contact lens discontinuation due to complaints of dry eye is the major contact lens problem today. A leading cause of complaints is the amount of tear lipid taken up by the contact lenses. Two factors which affect the amount of tear lipid taken up are the wearer tear film and the material from which the contact lenses are made. Some wearers tear films contain large amount of lipids that deposit on the contact lens and create problems (they are referred as high lipid depositors). At present, Silicone hydrogel (SiHy) contact lenses (CL) are the main CL type used because of their superior overall physiological benefits. Their main issue is the presence of silicone influences lipid uptake which consequently affects lens wettability and leads to reduced comfort and blurry vision. The amount of lipid taken up by CL also depends highly on the type of silicone hydrogel material they are made from, some attracting low amount, some high amount when measured in the laboratory. Hence the importance of understanding the clinical effects of selecting specific materials for the high risk wearers (high lipid depositor)and to provide science based advice to CL wearers, is the purpose of this study. The study will compare the difference in total lipid absorption of two types of CE marked SiHy CL (one with low and one with high lipid deposition in the laboratory) after 30 days of daily wear (30 days is the normal replacement period and the problem is worse at that time). The study will be a single site study in UK: approximately 140 existing CL wearing participants will be screened with approximately 78 high depositor entering the investigational phase. The study will involve six clinic visits (screening phase: 2 visits, investigational phase- 4 visits) for a total of 10.5 hour.
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
17/WM/0314
Date of REC Opinion
11 Sep 2017
REC opinion
Further Information Favourable Opinion