Comparison of Lotrafilcon B Lenses with Different Packaging Solutions
Research type
Research Study
Full title
One Month Clinical Comparison of Two Lotrafilcon B Spherical Lenses with Different Packaging Solutions
IRAS ID
200528
Contact name
Michel Guillon
Contact email
Sponsor organisation
Alcon Research Ltd.
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 5 months, 16 days
Research summary
Alcon Laboratories has incorporated a surfactant called HYDRAGLYDE into the packaging of its AIR OPTIX AQUA (AOA) contact lenses in order to improved the overall wettability of the lenses when they are worn on the eye. The purpose of this clinical study is to demonstrate that the lens fitting characteristics are not inferior in AIR OPTIX plus HYDRAGLYDE (AOHG) contact lenses when compared to AIR OPTIX AQUA contact lenses and to determine the effect of the added HYDRAGLYDE to AIR OPTIX lenses on tear film stability. \n\nThe study is to be conducted by the OTG-i, Research Clinic in London. A second site may be selected to participate in the study if necessary.\n\nCurrent wearers of AIR OPTIX AQUA (AOA) contact lenses will be eligible to participate in the study. Participants will wear both study lenses in 2 study periods. Each period will last for approximately one month. Participants will be assigned to either Group 1 or Group 2, based upon their availability to attend the scheduled study visits. Participants assigned to Group 1 will attend up to 9 scheduled visits. Participants assigned to Group 2 will attend up to 5 scheduled visits. Within each group, participants will be randomly assigned in a 1:1 manner to either receive AOA or AOHG contact lenses for use during Period 1 of the study. For Period 2, the contact lenses that were not allocated for use in Period 1 will then be dispensed.\n\nParticipants assigned to Group 1 will follow be required to return to the study site 3 times during the same day (early morning, afternoon and evening) on 2 occasions, and will undergo additional assessments of the wettability of the contact lenses by the tear film.\n\nAll participants will be expected to receive and respond to daily text messages regarding their experience with the lenses.\n
REC name
London - Fulham Research Ethics Committee
REC reference
16/LO/0716
Date of REC Opinion
3 May 2016
REC opinion
Further Information Favourable Opinion