Clinical Evaluation of HPT Treated Rigid Contact Lenses Made From Roflufocon D
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: HPT treated Hydra-PEG Treatment (HPT) treated RGP contact lenses made from roflufocon D |
Device: roflufocon D contact lenses
HPT treated rigid contact lenses
|
| Active Comparator: untreated untreated RGP contact lenses made from roflufocon D |
Device: RGP contact lenses made from roflufocon D
|
Outcome Measures
Primary Outcome Measures
- 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'.
- conjunctival redness - ocular biomicroscopy [subjects will be followed-up for one month]
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]
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.
Eligibility Criteria
Criteria
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
- 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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Siehste | Kassel | Germany |
Sponsors and Collaborators
- Contamac Ltd
- Hartwig Research Center
Investigators
- Principal Investigator: Andreas Hartwig, PhD, FAAO, Hartwig Research Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CM-002-001