Clinical Evaluation of HPT Treated Rigid Contact Lenses Made From Roflufocon D
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|ClinicalTrials.gov Identifier: NCT02553681|
Recruitment Status : Completed
First Posted : September 17, 2015
Last Update Posted : August 12, 2020
|Condition or disease||Intervention/treatment||Phase|
|Ametropia||Device: roflufocon D contact lenses Device: RGP contact lenses made from roflufocon D||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Clinical Evaluation of Hydra-PEG (Polyethylene Glycol) Treatment (HPT) Treated Rigid Contact Lenses Made From Roflufocon D|
|Study Start Date :||July 2015|
|Actual Primary Completion Date :||February 2017|
|Actual Study Completion Date :||February 16, 2017|
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
- questionnaire addressing subjective comfort and wear time [ 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'.
- conjunctival redness - ocular biomicroscopy [ 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.
- corneal staining - ocular biomicroscopy [ 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02553681
|Principal Investigator:||Andreas Hartwig, PhD, FAAO||Hartwig Research Center|