Clinical Evaluation of HPT Treated Rigid Contact Lenses Made From Hexafocon A
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04525170|
Recruitment Status : Withdrawn (It was decided by the sponsor to not proceed.)
First Posted : August 25, 2020
Last Update Posted : August 25, 2020
|Condition or disease||Intervention/treatment||Phase|
|Ametropia||Device: HPT treatment Device: untreated||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 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 Hexafocon A|
|Actual Study Start Date :||September 2015|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
Experimental: HPT treated
daily wear Hexafocon A rigid contact lens treated with Hydra PEG surface coating
Device: HPT treatment
Other Name: Hydra-PEG (Polyethylene Glycol) Treatment
daily wear Hexafocon A rigid contact lens
- 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'.
- limbal redness - ocular biomicroscopy [ Time Frame: 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 [ Time Frame: 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.
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): NCT04525170
|Hartwig Research Center|
|Heikendorf, S-H, Germany, 24226|
|Principal Investigator:||Andreas Hartwig, PhD||Hartwig Research Center|