Astigmatism Eye Diseases
Conditions
Interventions
Participants will attend the clinic for two study visits about 10 hours apart and complete a series of remote questionnaires while wearing the study contact lenses. At the first visit the participant
Sponsors
CooperVision International Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18 to 35 years 2. Best corrected visual acuity in each eye of 20/25 3. Control population: 3.1. Current spherical contact lens wearer but not MyDay® 3.2. Spectacle refraction: Sphere: -6.00D to + 2.00D Astigmatism: 0.00D to -0.75D 4. Test population: 4.1. Current toric contact lens wearer but not MyDay® toric 4.2. Spectacle refraction: Sphere: -6.00D to + 2.00D Astigmatism: -0.75D to -1.25D The prospective participants will be given a Participant Information Sheet to read and an Informed Consent Form to sign prior to any evaluation
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 |
|---|---|
| Contact lens comfort measured using a 100-point Visual Analogue Scale (VAS) at the end of the wearing period (10 hours) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Exposed contact lens surface area under the curve at selected timepoints post eye opening at insertion and at the end of the wearing period, measured from tear film digital video recording using the tearscope lighting system during the investigational visit 2. Contact lens decentration classification at the end of the wearing period measured using a four-point forced choice scale 3. Ease of contact lens insertion and removal measured using a 100-point visual analogue scale (VAS) during the visit | — |
Countries
England, United Kingdom
Contacts
Public ContactDeborah Moore
Outcome results
None listed