Ametropia
Conditions
Brief summary
Comparison of different contact lens materials.
Detailed description
This is a 1-month, open-label, bilateral, parallel-group, randomised, daily wear study. Two-thirds of the subjects will wear the Test lenses in both eyes, and one-third will wear the Control lenses in both eyes.
Interventions
DEVICEDefinitive 65 HPT contact lenses
DEVICEDefinitive 65 contact lenses
Sponsors
Hartwig Research Center
Contamac Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* willing and able to sign informed consent form * ages 18 years or older * Subjects must have owned spectacles or contact lenses prior to enrolment for this trial * Spherical power between -10.00 D and +10.00 D (at vertex distance 0 mm) * Astigmatic power ≤0.75 D
Exclusion criteria
* Eye injury or surgery within 3 months immediately prior to enrolment for this trial * Pre-existing ocular irritation that would preclude contact lens fitting * Currently enrolled in an ophthalmic clinical trial * Evidence of systemic or ocular abnormality, infection or disease which is likely to affect successful wear of contact lenses or use of the accessory solutions, as determined by the investigator * Any use of medications for which contact lens wear could be contradicted, as determined by the investigator * Current extended-wear users (sleep-in overnight) * Current monovision lens wearers * Pregnant women and nursing mothers * Best-corrected visual acuity worse than 6/9 (LogMAR: +0.20; Snellen decimal: 0.63)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| questionnaire addressing subjective comfort and wear time | subjects will be followed-up for one month | Subjects rated on a scale from 1 to 10, where 1 was 'poor' and 10 was 'excellent'. |
| limbal redness - ocular biomicroscopy | subjects will be followed-up for one month | Assessed using slit lamp with white light, low-medium magnification. Graded based on a grading scale which ranged from 0 to 4, where 0 is none, 1 is trace, 2 is mild, 3 is moderate and 4 is severe. |
| conjunctival redness - ocular biomicroscopy | subjects will be followed-up for one month | Assessed using slit lamp with white light, low-medium magnification. Graded based on a grading scale which ranged from 0 to 4, where 0 is none, 1 is trace, 2 is mild, 3 is moderate and 4 is severe. |
| corneal staining - ocular biomicroscopy | subjects will be followed-up for one month | Assessed using slit lamp with white light, low-medium magnification. Graded based on a grading scale which ranged from 0 to 4, where 0 is none, 1 is trace, 2 is mild, 3 is moderate and 4 is severe. |
Countries
Germany
Outcome results
None listed