Ignite Creation Date:
2024-05-06 @ 3:33 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04670263
Status:
COMPLETED
Last Update Posted:
2022-07-12
First Post:
2020-11-29
Brief Title:
Evaluating the Efficacy of Dry Eye DE Disease Treatment Using Novel Tear Film Imager TFI
Sponsor:
Adom Advanced Optical Technologies Ltd
Organization:
Adom Advanced Optical Technologies Ltd
Study Overview
Official Title:
Evaluating the Efficacy of Dry Eye DE Disease Treatment Using Novel Tear Film Imager TFI
Status:
COMPLETED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Dry Eye disease signs and symptoms are reduced in patients who receive topical steroids and topical hyaluronic acid
AdOMs Tear Film Imager measurements are reproducible and it can diagnose the dry eye disease state in a single non-invasive measurement The Tear Film Imager can provide objective accurate measurements of the dry eye treatment effectiveness
AdOMs Tear Film Imager measurements are reproducible and it can diagnose the dry eye disease state in a single non-invasive measurement The Tear Film Imager can provide objective accurate measurements of the dry eye treatment effectiveness
Detailed Description:
80 subjects will be enrolled 40 of which with positive signs and symptoms of Dry eye and 40 healthy subjects without sign and no symptoms of Dry eye Healthy and Dry eye groups will be age- matched
Over a period of 4 weeks the subjects diagnosed with dry eye will be treated and as follows
1 Hylo-comod artificial tears 01 sodium hyaluronate 8 times a day for 4 weeks
2 Coll STERODEX Dexamethasone sodium phosphate 01 eye drops 3 times a day for 2 weeks Healthy subjects will not receive any treatment
Both groups will be examined at baseline and 4 weeks after baseline measurement
Treatment results will be measured by both traditional methods and by Tear Film Imager
Over a period of 4 weeks the subjects diagnosed with dry eye will be treated and as follows
1 Hylo-comod artificial tears 01 sodium hyaluronate 8 times a day for 4 weeks
2 Coll STERODEX Dexamethasone sodium phosphate 01 eye drops 3 times a day for 2 weeks Healthy subjects will not receive any treatment
Both groups will be examined at baseline and 4 weeks after baseline measurement
Treatment results will be measured by both traditional methods and by Tear Film Imager
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None