Siehste
Kassel, Germany
NCT Number: NCT02553681
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Kassel, Germany
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
• Eye injury or surgery within 3 months immediately prior to enrolment for this trial
HPT treated rigid contact lenses
Time frame: 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'.
Time frame: 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.
Time frame: 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.
Contamac Ltd
Industry
Clinical Evaluation of Hydra-PEG (Polyethylene Glycol) Treatment (HPT) Treated Rigid Contact Lenses Made From Roflufocon D
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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