RPS InflammaDry Detector™ to Determine MMP-9 Levels in Tears
Source: ClinicalTrials.gov NCT01313351 ↗Summary
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sensitivity and Specificity of InflammaDry Detector Compared to Clinical Assessment at Confirming a Diagnosis of Dry Eyes. |
85; 94 | — |
Eligibility Criteria
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
- Schirmer's Tear Test (with anesthesia) < 10 mm over 5 minutes
- Tear Film Break Up Time (TBUT) < 10 seconds
- 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
- Schirmer's Tear Test (with anesthesia) ≥ 10 mm over 5 minutes
- Tear Film Break Up Time (TBUT) ≥ 10 seconds
- 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
Data sourced from ClinicalTrials.gov (NCT01313351). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.