Ametropia
Conditions
Brief summary
This will be an up to six months, subject-masked, contralateral, parallel-group, randomised, daily wear study. All subjects will wear the Test lens in one eye and the Control lens in the other eye. Data from the first four weeks of Test and Control lens exposure will be used for the FDA 510 (k) submission.
Interventions
DEVICEHPT treatment
DEVICEuntreated
Sponsors
Contamac Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Willing and able to sign the informed consent form * Aged ≥18 years old * Experienced wearer of rigid gas permeable contact lenses * Subject's habitual contact lenses must be made of Boston XO (hexafocon A) material * 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) * Corneal astigmatism ≤2.00 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 * Current wearers of multifocal contact lenses * Current wearers of toric contact lenses (front surface design) * Current wearers of astigmatic contact lenses (posterior surface design) * Has a reported Strong comfort or vision preference between each eye with their habitual RGP lenses * Unacceptable fit of habitual lenses * 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 | Findings were 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 | Findings were 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