N/A
N=237
Clinical Evaluation of the InflammaDry Device for Detecting Dry Eye
Dysfunctional Tear Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT01692964 ↗Enrolled (actual)
237
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcome: Primary: Negative and Positive Agreement of the InflammaDry at Diagnosis of Dry Eyes — 81; 98; 86; 97 percentage of cases
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- InflammaDry (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Rapid Pathogen Screening
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Negative and Positive Agreement of the InflammaDry at Diagnosis of Dry Eyes |
81; 98; 86; 97 | — |
Summary
InflammaDry is a rapid diagnostic test for the detection of elevated levels of Matrix Metalloproteinase-9 (MMP-9) protein in tear fluid.
Eligibility Criteria
Inclusion Criteria
- 18 years of age or older
- Patient voluntarily reported at least 1 episode of any of the following ocular symptoms during the last month:
- Burning or stinging
- Sandy or gritty feeling
- Foreign body sensation
- Tearing
- Light sensitivity
- Intermittent or fluctuating vision
- Tired eyes
Exclusion Criteria
- Allergy to cornstarch or Dacron
- Allergy to topical anesthetic or fluorescein dye
- Prior eye injury, trauma, or ocular surgery within the last 3 months
- Known blockage of the lacrimal drainage system
- Contact lens wear in the last month
- Previous corneal refractive surgery including RK, LASIK or PRK surgery
- Have an active ocular infection or history of a recent ocular infection in the last month
- Have active intraocular inflammation or history of intraocular inflammation, e.g. Uveitis
- Use of oral doxycycline, corticosteroids, or immunomodulators in the last month
- Have received topical ocular corticosteroids, topical Nonsteroidal (NSAIDs) therapy, or topical ocular cyclosporine in the last month
- Pregnant or lactating
- Use of any topical ophthalmic medications, including artificial tears 2 hours prior to enrollment
Data sourced from ClinicalTrials.gov (NCT01692964). 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.