Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-28 @ 9:34 PM
Study NCT ID:
NCT01313351
Status:
COMPLETED
Last Update Posted:
2022-12-12
First Post:
2011-03-03
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
RPS InflammaDry Detector™ to Determine MMP-9 Levels in Tears
Sponsor:
Rapid Pathogen Screening
Organization:
Study Overview
Official Title:
A Clinical Evaluation of the RPS InflammaDry Detector's Sensitivity and Specificity Compared to the Clinical Diagnosis for Confirming Dry Eyes.
Status:
COMPLETED
Status Verified Date:
2022-11
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:
The RPS InflammaDry Detector™ is intended to detect elevated MMP-9 in human tears to aid in the diagnosis of patients with signs or symptoms of dry eye disease, in conjunction with other methods of clinical evaluation.
Detailed Description:
The purpose of this clinical trial was to determine the sensitivity and specificity of InflammaDry compared with the clinical assessment of dry eyes.
Patients were screened using clinical history and signs.
Clinical history was performed using the Ocular Surface Disease Index (OSDI) and evaluated for clinical signs:
* positive vital staining of the ocular surface,
* decreased tear breakup time (TBUT),
* reduced corneal sensitivity, and
* decreased functional visual acuity Last, an independent health care professional masked to the clinical evaluation was asked to analyze each InflammaDry test result, independently confirming each result.
Patients were screened using clinical history and signs.
Clinical history was performed using the Ocular Surface Disease Index (OSDI) and evaluated for clinical signs:
* positive vital staining of the ocular surface,
* decreased tear breakup time (TBUT),
* reduced corneal sensitivity, and
* decreased functional visual acuity Last, an independent health care professional masked to the clinical evaluation was asked to analyze each InflammaDry test result, independently confirming each result.
Study Oversight
Has Oversight DMC:
False
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?: