Three-month Clinical Evaluation of DSiHy Daily Disposable Silicone Hydrogel Contact Lenses

Hoya

Status

Unknown

Conditions

Contact Lenses

Treatments

Device: CE-marked Silicone hydrogel soft contact lens

Device: DSiHy Silicone hydrogel soft contact lens

Study type

Interventional

Funder types

Industry

Identifiers

NCT03859440

HOYA-3601

Details and patient eligibility

About

The purpose of this study is to evaluate the clinical performance of two daily disposable silicone hydrogel contact lenses. One of these lenses, the 'test' lens is an investigational product. This means that it has not yet been approved for commercial use and is not available for sale. The other lens (control) is a commercially available contact lens.

The results of this study will be analysed to determine how the 'test' lens compares with the 'control' lens. The control lens has been chosen because it is a market leader and is well tried and tested.

Participants who are in this study will need to have healthy eyes, except for the need to correct their eyesight. Up to 90 people who are aged 20 years or older will be considered for participation in this study. The study is designed to be approximately 3 months long.

Enrollment

90 estimated patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Be aged 20 years or more.
Sign written informed consent.
Be a currently adapted soft contact lens wearer (i.e. be wearing lenses at least 1 month prior to enrolment).
Contact lens sphere requirement between -1.00 to -6.00 D (inclusive).
Refractive astigmatism (if present) less than or equal to 0.75 D in both eyes.
Be correctable by sphero-cylindrical refraction to 6/7.5 (+0.10 logMAR 0.8 decimal) or better in each eye.
Require visual correction in both eyes (monovision allowed, no monofit.

Exclusion criteria

Require toric or multifocal contact lenses.
Concurrent ocular medication.
Using systemic or topical medications that will in the investigator's opinion affect ocular physiology or contact lens performance.
Any systemic illness affecting contact lens wear or the medical treatment of which would affect vision or successful lens wear (including diabetes).
Clinically significant (≥Grade 2) corneal staining, corneal edema, corneal vascularization, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate contact lens wear.
History of herpetic keratitis.
Pathological dry eye.
Aphakia or amblyopia.
History of refractive surgery, keratoconus or other corneal irregularity.
Pregnancy, lactating or planning a pregnancy at the time of enrolment.
Participation in any concurrent clinical trial or within the last 30 days.