Astigmatism Eye Diseases
Conditions
Interventions
Two types of contact lenses (MyDay Toric®, MyDay® spherical) will be worn by each participant in a random order in turn for at least 7 days (7 -0./+3 days) on a daily disposable basis. Randomisation i
Sponsors
CooperVision International Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: In order to be enrolled, each participant shall meet the following criteria: 1. Aged 18 to 35 years 2. Current contact lens wearer 3. Spectacle refraction: Distance: Sphere: -6.00D to + 2.00D Astigmatism: -0.50D to -1.00D with at least -0.75D in one eye 4. Best corrected visual acuity of at least 20/25 in each eye
Exclusion criteria
Exclusion criteria: 1. Acute and subacute inflammation or infection of the anterior chamber of the eye 2. Any eye disease, injury or abnormality that affects the cornea, conjunctiva or eyelids that would contraindicate contact lens wear 3. Corneal hypoesthesia (reduced corneal sensitivity), if not aphakic 4. Severe insufficiency of lacrimal secretion (dry eyes) 5. Any systemic disease that may affect the eye or may be exaggerated by wearing contact lenses (e.g. acne and eczema) 6. Allergic reactions of ocular surfaces or adnexa that may be induced or exaggerated by wearing contact lenses or use of contact lens solutions 7. Any active corneal infection (bacterial, fungal, protozoal or viral) 8. Newly prescribed (within the past 30 days) use of some systemic medications (such as antihistamines, decongestants, diuretics, muscle relaxants, tranquilizers, stimulants, anti-depressants, anti-psychotics, oral contraceptives) or new prescription eyedrops which is not rewetting/lubricating eyedrops for which contact lens wear could be contraindicated as determined by the investigator 9. Monocular participants (only one eye with functional vision) or participants fit with only one contact lens 10. Subjects with slit lamp findings greater than grade 1 (e.g. edema, infiltrates, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival, anterior segment inflammation) as per ISO 11980, any previous history or signs of a contact lens related corneal inflammatory event (past corneal ulcers), or any other ocular abnormality that may contraindicate contact lens wear at the enrolment visit 11. History of corneal refractive surgery 12. Enrolment of the family members of the investigator, family members of the investigator’s staff, or individuals living in the households of these individuals 13. Current wearer of the control contact lenses MyDay® spherical or the test contact lenses MyDay Toric®
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timed monocular logMAR high contrast (>90%), mesopic (2.5 cd/m2) visual acuity measured at the follow-up visits at 7 (+3/-0), 14 (+3/-0) and 21 (+3/-0) days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Overall night-time vision satisfaction recorded on a 100-point VAS measured at the follow-up visits at 7 (+3/-0), 14 (+3/-0) and 21 (+3/-0) days 2. Timed monocular logMAR medium contrast, mesopic (2.5 cd/m2) visual acuity loss with the addition of a glare source measured at the follow-up visits at 7 (+3/-0), 14 (+3/-0) and 21 (+3/-0) days | — |
Countries
England, United Kingdom
Contacts
Public ContactDeborah Moore
Outcome results
None listed