Contact lens wettability Eye Diseases
Conditions
Interventions
This study is a double-masked prospective randomized cross-over study involving three study visits, an initial screening, and an enrolment fitting visit, followed by two test visits using two differen
Sponsors
Optometric Technology Group Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged from 18 to 75 years old 2. Current daily disposable hydrogel or silicone hydrogel spherical contact lens wearer to represent a normal contact lens-wearing population 3. Spectacle refraction: Distance: Sphere: -6.00D to + 2.00D; Astigmatism: 0.00D to -0.75 4. Best corrected visual acuity of at least 20/25 in each eye
Exclusion criteria
Exclusion criteria: 1. Habitual wearer of one of either of the two study contact lenses 2. Acute and subacute inflammation or infection of the anterior chamber of the eye 3. Any eye disease, injury or abnormality that affects the cornea, conjunctiva or eyelids that would contraindicate contact lens wear 4. Corneal hypoesthesia (reduced corneal sensitivity), if not aphakic 5. Severe insufficiency of lacrimal secretion (dry eyes) 6. Any systemic disease that may affect the eye or may be exaggerated by wearing contact lenses (e.g. acne and eczema) 7. Allergic reactions of ocular surfaces or adnexa that may be induced or exaggerated by wearing contact lenses or use of contact lens solutions 8. Any active corneal infection (bacterial, fungal, protozoal or viral) 9. Newly prescribed (within the past 30 days) use of some systemic medications (such as antihistamines, decongestants, diuretics, muscle relaxants, tranquillizers, 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 10. Monocular participants (only one eye with functional vision) or participants fit with only one contact lens 11. 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 12. History of corneal refractive surgery 13. Enrolment of the family members of the investigator, family members of the investigator’s staff, or individuals living in the households of these individuals
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Monocular static logMAR visual acuity high luminance (250 cd/m2), high contrast (>90%), distance (4 m) measured at each of the study visits | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary outcome measures will be assessed at each of the study visits: 1. Contact lens comfort measured using a 100-point visual analog scale 2. Visual performance for distance, intermediate and near distances measured using the OTG-i Vision Suite Landolt ring high luminance (250 cd/m2), distance (4 m), monocular timed control monocular contrast sensitivity test (3, 6, 12, 18 cycles per degree) 3. Pre-contact lens tear film measured using a tearscope over 30 seconds interblink period | — |
Countries
England, United Kingdom
Contacts
Public ContactDeborah Moore
Outcome results
None listed