Trial Outcomes & Findings for Clinical Evaluation of the InflammaDry Device for Detecting Dry Eye (NCT NCT01692964)

Results Overview

Negative agreement is the percentage of true negative cases compared to clinical assessment (specificity). Positive agreement is the percentage of true positive cases compared to clinical assessment (sensitivity). The InflammaDry test was compared with the clinical assessment of tear break-up time, Schirmer tear testing, and corneal staining for the confirmation of dry eye, both with and without the inclusion of the Ocular Surface Disease Index (OSDI), as a confirmatory test.

Recruitment status

COMPLETED

Target enrollment

237 participants

Primary outcome timeframe

20 minutes

Results posted on

2020-10-12

Participant Flow

The recruitment took place over a 7-month period. The study was performed at private practices and academic centers.

Participant milestones

Participant milestones
Measure	InflammaDry Patients suspected of having dry eye will be tested with the InflammaDry. InflammaDry: A noninvasive immunoassay for detecting MMP-9 levels in tears.
Overall Study STARTED	237
Overall Study COMPLETED	237
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Evaluation of the InflammaDry Device for Detecting Dry Eye

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	InflammaDry n=237 Participants Patients suspected of having dry eye will be tested with the InflammaDry. InflammaDry: A noninvasive immunoassay for detecting MMP-9 levels in tears.
Age, Customized	53 years n=93 Participants
Sex: Female, Male Female	164 Participants n=93 Participants
Sex: Female, Male Male	73 Participants n=93 Participants
Region of Enrollment United States	237 participants n=93 Participants

PRIMARY outcome

Timeframe: 20 minutes

Negative agreement is the percentage of true negative cases compared to clinical assessment (specificity). Positive agreement is the percentage of true positive cases compared to clinical assessment (sensitivity). The InflammaDry test was compared with the clinical assessment of tear break-up time, Schirmer tear testing, and corneal staining for the confirmation of dry eye, both with and without the inclusion of the Ocular Surface Disease Index (OSDI), as a confirmatory test.

Outcome measures

Outcome measures
Measure	InflammaDry (Sensitivity) n=237 Participants Looking for the percentage of true positives as compared to clinical assessment.	Inflammadry (Specificity) n=237 Participants Looking for the percentage of true negatives as compared to clinical assessment.
Negative and Positive Agreement of the InflammaDry at Diagnosis of Dry Eyes Confirmatory Testing With OSDI Inclusion	81 percentage of cases Interval 74.0 to 87.0	98 percentage of cases Interval 91.0 to 100.0
Negative and Positive Agreement of the InflammaDry at Diagnosis of Dry Eyes Confirmatory Testing Without OSDI Inclusion	86 percentage of cases Interval 80.0 to 91.0	97 percentage of cases Interval 91.0 to 99.0

Adverse Events

InflammaDry

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: 941-556-1853

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Publications shall be submitted to the Sponsor for review/comment 45 days prior to publication. Sponsor may remove confidential information. First publication shall be a multicenter study publication. Institution and/or PI may publish or present the results and data from the Institution's site individually (i) 12 months after conclusion, abandonment or termination of study at all sites, or (ii) after the Sponsor confirms there will be no multicenter study publication, whichever occurs first.
Publication restrictions are in place

Restriction type: OTHER