## Protocol Section
### Identification Module
**NCT ID:** NCT02315079

**Brief Title:** Point of Care Testing of Inflammatory Markers in Tears

**Official Title:** Point of Care Testing of Inflammatory Markers in Tears

#### Organization Study ID Info
**ID:** IRB201400775
#### Organization
**Class:** OTHER
**Full Name:** University of Florida
### Status Module
#### Completion Date
**Date:** 2017-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-07-24

**Type:** ACTUAL

**Last Update Submit Date:** 2019-07-23

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2017-01

**Type:** ACTUAL

#### Start Date
**Date:** 2015-01

**Status Verified Date:** 2019-07

#### Study First Post Date
**Date:** 2014-12-11
**Type:** ESTIMATED
**Study First Submit Date:** 2014-12-09
**Study First Submit QC Date:** 2014-12-10
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Florida

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** To evaluate the use of a point of care device to measure markers of inflammation in various eye conditions. In particular, matrix metalloproteinase-9 (MMP-9) will be measured. MMP-9 is an enzyme that plays a role in inflammation. The value obtained with the point of care device will be correlated with values obtained using gel electrophoresis to measure MMP-9 from the same sample. These data will be compared to clinical exam findings and questionnaires to help the investigators better understand the role of this marker of inflammation in eye diseases and possibly improve diagnostic abilities.

**Detailed Description:** As a participant in the study a sample of tears will be collected in a non-invasive manner by sitting comfortably at the slit lamp (a slit lamp is the standard device used to examine the eye and merely requires the participant to sit upright and place their chin on a chin rest and their forehead up against the slit lamp apparatus). The participant will then be asked to look upwards and while gently lowering the lower eyelid, a sterile blunt glass pipette will be used to collect tears from the natural tear lake (the tear lake is a reservoir of tears that sits on the surface of the eye and above the lower eyelid). Collected tears will then be taken for analysis of inflammatory markers.

In addition, a survey to evaluate the symptoms and the symptoms impact daily life (Ocular Surface Disability Index Survey of National Eye Institute Visual Functioning Questionnaire- 25).

### Conditions Module

**Conditions:**

- Dry Eye Syndrome

**Keywords:**

- Ocular Inflammation

- Matrix Metalloproteinase 9

### Design Module

#### Bio Spec

**Description:** de-identified tear samples

**Retention:** SAMPLES_WITHOUT_DNA

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 63

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** This group will have a regular eye exam with the collection of tears. In addition, a the Ocular Surface Disability Index Survey of National Eye Institute Visual Functioning Questionnaire- 25 may be administered.

**Intervention Names:**

- Other: Eye inflammation

**Label:** Eye inflammation

#### Arm Group 2

**Description:** This group will have a regular eye exam with the collection of tears.

**Intervention Names:**

- Other: Without eye inflammation

**Label:** Without eye inflammation

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Eye inflammation

**Description:** This group will have a regular eye exam with the collection of tears. In addition, a the Ocular Surface Disability Index Survey of National Eye Institute Visual Functioning Questionnaire- 25 may be administered.

**Name:** Eye inflammation

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Without eye inflammation

**Description:** This group will have a regular eye exam with the collection of tears.

**Name:** Without eye inflammation

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Measure:** Measurement of matrix metalloproteinase-9 in tears

**Time Frame:** Baseline

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patients that present to clinic for evaluation. Patients with and without evidence of eye inflammation will be eligible for this study.

Exclusion Criteria:

* Patients outside the age limits will not be eligible for the study

**Healthy Volunteers:** True

**Maximum Age:** 90 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Patients aged 18-90 years of age that present to our North Central Florida Tertiary Referral University Eye Clinics for evaluation. Patients with and without evidence of eye inflammation will be eligible for this study.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Gainesville

**Country:** United States

**Facility:** University of Florida, Department of Ophthalmology

**State:** Florida

**Zip:** 32610

#### Overall Officials

**Official 1:**

**Affiliation:** University of Florida, Department of Ophthalmology

**Name:** Sonal Tuli, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007766

- Term: Lacrimal Apparatus Diseases

- ID: D000005128

- Term: Eye Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC11

- Name: Eye Diseases

- Abbrev: BC26

- Name: Wounds and Injuries

### Condition Browse Module - Browse Leaves

- ID: M10293

- Name: Inflammation

- Relevance: LOW

- As Found: Unknown

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M18040

- Name: Dry Eye Syndromes

- Relevance: HIGH

- As Found: Dry Eye Syndrome

- ID: M10664

- Name: Keratoconjunctivitis Sicca

- Relevance: LOW

- As Found: Unknown

- ID: M15241

- Name: Rupture

- Relevance: LOW

- As Found: Unknown

- ID: M22785

- Name: Lacerations

- Relevance: LOW

- As Found: Unknown

- ID: M10786

- Name: Lacrimal Apparatus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8271

- Name: Eye Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000015352

- Term: Dry Eye Syndromes

### Misc Info Module

- Version Holder: 2024-05-24
