Clinical Evaluation of HPT Treated Rigid Contact Lenses Made From Roflufocon D

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Evaluation of Hydra-PEG (Polyethylene Glycol) Treatment (HPT) Treated Rigid Contact Lenses Made From Roflufocon D

Conditions
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Ametropia

Intervention / Treatment
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* Device: roflufocon D contact lenses
* Device: RGP contact lenses made from roflufocon D


Participation Criteria
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Eligibility Criteria
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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 Contamac's Optimum Extra (roflufocon D) 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HPT treated<br>Hydra-PEG Treatment (HPT) treated RGP contact lenses made from roflufocon D | Device: roflufocon D contact lenses<br>* HPT treated rigid contact lenses<br>|
| Active Comparator: untreated<br>untreated RGP contact lenses made from roflufocon D | Device: RGP contact lenses made from roflufocon D<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| questionnaire addressing subjective comfort and wear time | Subjects rated on a scale from 1 to 10, where 1 was 'poor' and 10 was 'excellent'. | subjects will be followed-up for one month | 
| conjunctival redness - ocular biomicroscopy | 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. | subjects will be followed-up for one month | 
| corneal staining - ocular biomicroscopy | 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. | subjects will be followed-up for one month |