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Trial Outcomes & Findings for RPS InflammaDry Detector™ to Determine MMP-9 Levels in Tears (NCT NCT01313351)

NCT ID: NCT01313351

Last Updated: 2022-12-12

Results Overview

Patients were assessed for signs and Symptoms of Dry Eye using OSDI (Ocular Surface Disease Index), TBUT (Fluorescein Tear Break-up Time), Corneal fluorescein staining and Schirmer Tear Test and compared to the results of the tested device. Sensitivity is the percentage of true positive cases correctly identified by the test, compared to clinical assessment. Specificity is the percentage of true negative cases correctly identified by the test, compared to clinical assessment.

Recruitment status

COMPLETED

Target enrollment

206 participants

Primary outcome timeframe

15 minutes

Results posted on

2022-12-12

Participant Flow

Participant milestones

Participant milestones
Measure
Device Testing
Tears were collected from subjects to apply to the RPS InflammaDry detector and were clinically evaluated. RPS InflammaDry Detector™: A noninvasive immunoassay for detecting MMP-9 levels in tears
Overall Study
STARTED
206
Overall Study
COMPLETED
206
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

RPS InflammaDry Detector™ to Determine MMP-9 Levels in Tears

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
InflammaDry Test
n=206 Participants
Tears were collected from subjects to apply to the RPS InflammaDry detector and were clinically evaluated. RPS InflammaDry Detector™: A noninvasive immunoassay for detecting MMP-9 levels in tears
Age, Continuous
53 years
n=5 Participants
Sex: Female, Male
Female
152 Participants
n=5 Participants
Sex: Female, Male
Male
54 Participants
n=5 Participants
Race/Ethnicity, Customized
Race · White
136 Participants
n=5 Participants
Race/Ethnicity, Customized
Race · Black
11 Participants
n=5 Participants
Race/Ethnicity, Customized
Race · Hispanic
49 Participants
n=5 Participants
Race/Ethnicity, Customized
Race · Asian
9 Participants
n=5 Participants
Race/Ethnicity, Customized
Race · Other
1 Participants
n=5 Participants
Region of Enrollment
United States
206 participants
n=5 Participants

PRIMARY outcome

Timeframe: 15 minutes

Patients were assessed for signs and Symptoms of Dry Eye using OSDI (Ocular Surface Disease Index), TBUT (Fluorescein Tear Break-up Time), Corneal fluorescein staining and Schirmer Tear Test and compared to the results of the tested device. Sensitivity is the percentage of true positive cases correctly identified by the test, compared to clinical assessment. Specificity is the percentage of true negative cases correctly identified by the test, compared to clinical assessment.

Outcome measures

Outcome measures
Measure
InflammaDry Sensitivity
n=143 Participants
Percentage of True Positives when compared to Clinical Assessment
InflammaDry Specificity
n=63 Participants
Percentage of True Negatives when compared to Clinical Assessment
Sensitivity and Specificity of InflammaDry Detector Compared to Clinical Assessment at Confirming a Diagnosis of Dry Eyes.
85 percentage of cases
Interval 77.6 to 90.5
94 percentage of cases
Interval 84.5 to 98.2

Adverse Events

Device Testing

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Robert Sambursky, MD

Rapid Pathogen Screening, Inc

Phone: 9415581853

Results disclosure agreements

  • Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release.
  • Publication restrictions are in place

Restriction type: OTHER