HOYA 3601; Version 1
Research type
Research Study
Full title
Three-month clinical evaluation of DSiHy daily disposable silicone hydrogel contact lenses
IRAS ID
257264
Contact name
Graeme Young
Contact email
Sponsor organisation
HOYA Lamphum Ltd
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 5 months, 24 days
Research summary
The purpose of this study is to evaluate the clinical performance of a daily disposable silicone hydrogel contact lens, DSiHy (HOYA), which is not yet CE marked, against a control soft contact lens that is approved and CE marked.
The DSiHy (Hoya) is the test lens. MyDay (Coopervision) is the control lens
Approximately 6 sites located in the UK will each be expected to recruit approximately 15 subjects, for a study total of approximately 90 subjects. To take part in the study all subjects will be current wearers of soft contact lenses, with healthy eyes apart from the need to correct their vision.
The subjects will be randomly assigned to one of the two types of contact lenses to wear for the duration of the study. Approximately 66 to the test lens and 24 to the control lens.
Each subject will be expected to attend up to five scheduled study visits over a period of 13 weeks.REC name
HSC REC B
REC reference
19/NI/0055
Date of REC Opinion
4 Apr 2019
REC opinion
Further Information Favourable Opinion