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.

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.

INCLUSION CRITERIA

Patients older than 18 years of age, who meet the following criteria related to the clinical history and signs will be enrolled:

Group 1: Clinical Dry Eyes

Clinical History Criteria

An Ocular Surface Disease Index (OSDI) of greater than or equal to 13 - [Appendix #2]

Clinical Signs Criteria - All of the following must be present

1. Schirmer's Tear Test (with anesthesia) < 10 mm over 5 minutes

2. Tear Film Break Up Time (TBUT) < 10 seconds

3. Total Corneal Staining ≥ 1 [Appendix #1]

   • At least 1/2 of all patients enrolled will have a Schirmer's Tear Test < 5 mm or demonstrate corneal staining ≥ 2 [Appendix #1]

Group 2: Clinical Normal Non-Dry Eyes

Clinical History Criteria

An Ocular Surface Disease Index (OSDI) of < 7 - [Appendix #2]

Clinical Signs Criteria - All 3 of the following must be present

1. Schirmer's Tear Test (with anesthesia) ≥ 10 mm over 5 minutes
2. Tear Film Break Up Time (TBUT) ≥ 10 seconds
3. Total Corneal Staining = 0 [Appendix #1]

EXCLUSION CRITERIA

• Patients with allergy to corn starch, talcum powder, or dacron
• Patients with prior eye injury, trauma, or ocular surgery within the previous 3 months
• Patients with non-dry eye ocular inflammation, uveitis, history of herpetic keratitis or zoster keratitis
• Patients with history of a recent ocular infection within the prior 1 month
• Use of oral doxycycline or topical macrolides (AzaSite) within 1 month
• Patients currently receiving, or received in the last 2 weeks of the study , certain medications including topical or systemic corticosteroids, topical or systemic Nonsteroidal (NSAIDs) therapy, topical cyclosporine, or other immunosuppressive therapy
• Patients who are pregnant or lactating
• Before initialization of the study, patients must not have used any topical medications, including artificial tears during the previous 2 hours
• The use of Rigid-Gas permeable contact lenses or the use of soft-contact lenses within 1 month of the study

Only patients who met the inclusion criteria were included in the study.

15 minutes

Regular monitoring by sponsor and mandatory reporting by investigator