## Protocol Section
### Identification Module
**NCT ID:** NCT00991679

**Brief Title:** CXCL9, CXCL10, CXCL11, and CXCR3 in Dry Eye Syndrome

**Official Title:** Expression of CXCL9, CXCL10, CXCL11, and CXCR3 in the Tear Film and Ocular Surface of Patients With Dry Eye Syndrome

#### Organization Study ID Info
**ID:** I-2007-12-111
#### Organization
**Class:** OTHER
**Full Name:** Chonnam National University Hospital
### Status Module
#### Completion Date
**Date:** 2008-12

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2009-10-08

**Type:** ESTIMATED

**Last Update Submit Date:** 2009-10-07

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2008-10

**Type:** ACTUAL

#### Start Date
**Date:** 2008-02

**Status Verified Date:** 2009-10

#### Study First Post Date
**Date:** 2009-10-08
**Type:** ESTIMATED
**Study First Submit Date:** 2009-10-07
**Study First Submit QC Date:** 2009-10-07
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Chonnam National University Hospital

#### Responsible Party

**Old Name Title:** Kyung-Chul Yoon, MD/ Assisted professor

**Old Organization:** Department of Ophthalmology, Chonnam National University Medical School and Hospital, Gwangju, South Korea

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The aim of this study is to investigate the expression of CXCL9, CXCL10, CXCL11, and CXCR3 in the tear film and ocular surface of patients with dry eye syndrome.

Thirty-three patients with dry eye (16 Sjögren's syndrome and 17 non-Sjögren's syndrome patients) and 15 control subjects were recruited. The concentrations of CXCL9, CXCL10, and CXCL11 in tears were measured using enzyme-linked immunosorbent assay. The correlation between chemokine levels and tear film and ocular surface parameters was analyzed. Expression of CXCL9, CXCL10, CXCL11, and CXCR3 in the conjunctiva was evaluated using immunohistochemistry. Flow cytometry was performed to count CXCR3+ cells and CXCR3+CD4+ cells in the conjunctiva.

### Conditions Module

**Conditions:**

- Dry Eye Syndrome

**Keywords:**

- Dry eye syndrome

- CXCL9 chemokine

- CXCL10 chemokine

- CXCL11 chemokine

- CXCR3 receptor

### Design Module

#### Bio Spec

**Description:** tears, conjunctiva

**Retention:** SAMPLES_WITHOUT_DNA

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 48

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Normal control subjects who did not show the clinical symptom and findings of dry eye syndrome.

**Label:** Normal control subjects

#### Arm Group 2

**Description:** Patients with dry eye syndrome who had symptoms of dry eye for more than 3 months, low tear film break up time (BUT, ≤7 sec), low Schirmer test (\<10 mm), low tear clearance rate (\<8X), and positive fluorescein or rose bengal vital staining (≥3) and were not treated with anti-inflammatory agents such as topical cyclosporine or steroids were included in the study.

**Label:** dry eye patients

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* clinical diagnosis of dry eye syndrome

Exclusion Criteria:

* active ocular infection or inflammation not associated with dry eye
* drug toxicity
* contact lens wear
* ocular allergy
* ocular surgery within the last 3 months
* lid or lash abnormalities

**Healthy Volunteers:** True

**Maximum Age:** 77 Years

**Minimum Age:** 24 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Primary care clinic

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Gwangju

**Country:** Korea, Republic of

**Facility:** Chonnam National University Hospital

**State:** Chonnam

**Zip:** 501-757

#### Overall Officials

**Official 1:**

**Affiliation:** Department of Ophthalmology, Chonnam National University Medical School and Hospital, Gwangju, South Korea

**Name:** Kyung-Chul Yoon, MD, PhD

**Role:** STUDY_DIRECTOR

### References Module

#### References

**Citation:** Yoon KC, De Paiva CS, Qi H, Chen Z, Farley WJ, Li DQ, Pflugfelder SC. Expression of Th-1 chemokines and chemokine receptors on the ocular surface of C57BL/6 mice: effects of desiccating stress. Invest Ophthalmol Vis Sci. 2007 Jun;48(6):2561-9. doi: 10.1167/iovs.07-0002.

**PMID:** 17525185

**Citation:** Wallace GR, John Curnow S, Wloka K, Salmon M, Murray PI. The role of chemokines and their receptors in ocular disease. Prog Retin Eye Res. 2004 Jul;23(4):435-48. doi: 10.1016/j.preteyeres.2004.04.004.

**PMID:** 15219876

**Citation:** Pflugfelder SC, Jones D, Ji Z, Afonso A, Monroy D. Altered cytokine balance in the tear fluid and conjunctiva of patients with Sjogren's syndrome keratoconjunctivitis sicca. Curr Eye Res. 1999 Sep;19(3):201-11. doi: 10.1076/ceyr.19.3.201.5309.

**PMID:** 10487957

**Citation:** Yoon KC, Park CS, You IC, Choi HJ, Lee KH, Im SK, Park HY, Pflugfelder SC. Expression of CXCL9, -10, -11, and CXCR3 in the tear film and ocular surface of patients with dry eye syndrome. Invest Ophthalmol Vis Sci. 2010 Feb;51(2):643-50. doi: 10.1167/iovs.09-3425. Epub 2009 Oct 22.

**PMID:** 19850844

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000004194

- Term: Disease

- ID: D000010335

- Term: Pathologic Processes

- ID: D000007766

- Term: Lacrimal Apparatus Diseases

- ID: D000005128

- Term: Eye Diseases

- ID: D000007637

- Term: Keratoconjunctivitis

- ID: D000003231

- Term: Conjunctivitis

- ID: D000003229

- Term: Conjunctival Diseases

- ID: D000007634

- Term: Keratitis

- ID: D000003316

- Term: Corneal 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: M16355

- Name: Syndrome

- Relevance: HIGH

- As Found: Syndrome

- ID: M18040

- Name: Dry Eye Syndromes

- Relevance: HIGH

- As Found: Dry Eye Syndrome

- ID: M10664

- Name: Keratoconjunctivitis Sicca

- Relevance: HIGH

- As Found: Dry Eye Syndrome

- ID: M15241

- Name: Rupture

- Relevance: LOW

- As Found: Unknown

- ID: M22785

- Name: Lacerations

- Relevance: LOW

- As Found: Unknown

- ID: M10663

- Name: Keratoconjunctivitis

- 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

- ID: M6455

- Name: Conjunctivitis

- Relevance: LOW

- As Found: Unknown

- ID: M6453

- Name: Conjunctival Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10660

- Name: Keratitis

- Relevance: LOW

- As Found: Unknown

- ID: M6539

- Name: Corneal Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000015352

- Term: Dry Eye Syndromes

- ID: D000007638

- Term: Keratoconjunctivitis Sicca

- ID: D000013577

- Term: Syndrome

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: ARhu

- Name: Antirheumatic Agents

- Abbrev: Derm

- Name: Dermatologic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

### Intervention Browse Module - Browse Leaves

- ID: M18961

- Name: Cyclosporine

- Relevance: LOW

- As Found: Unknown

- ID: M6730

- Name: Cyclosporins

- Relevance: LOW

- As Found: Unknown

- ID: M4217

- Name: Anti-Inflammatory Agents

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
