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This is a multi-center, prospective, controlled, observational study of the natural history of patients with dry eye disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with dry eye | No treatment is prescribed for the study. Patient dry eye progression will be followed for up to 60 months. Patients may use artificial tears to treat their dry eye symptoms. |
| |
| Patients with no history of dry eye | No treatment is prescribed for this control group. Patients will be followed for up to 60 months. If needed, patients may use artificial tears. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Artificial Tears | Other | Artificial tears (any brand) may be used to treat dry eye symptoms. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients with Progression of Dry Eye Disease | Baseline, 60 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Ocular Surface Disease Index© (OSDI©) Score | Baseline, 60 Months | |
| Percentage of Patients with an Increase in Blurred Vision | Baseline, 60 Months | |
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Inclusion Criteria:
Exclusion Criteria:
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At least 200 dry eye patients (with at least 40% of patients with elevated biomarkers for ocular surface inflammation) will be enrolled at approximately 15-20 sites. Approximately 40-50 patients will be enrolled in the control group.
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| Name | Affiliation | Role |
|---|---|---|
| Tes Ignacio | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jones Eye Institute | Little Rock | Arkansas | 72205 | United States | ||
| North Valley Eye Medical Group, Inc. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29284427 | Derived | McDonnell PJ, Pflugfelder SC, Stern ME, Hardten DR, Conway T, Villanueva L, Hollander DA. Study design and baseline findings from the progression of ocular findings (PROOF) natural history study of dry eye. BMC Ophthalmol. 2017 Dec 28;17(1):265. doi: 10.1186/s12886-017-0646-5. |
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Tear collection
| Change from Baseline in Schirmer's Test |
| Baseline, 60 Months |
| Change from Baseline in Conjunctival Staining Score on a 6-Point Scale | Baseline, 60 Months |
| Change from Baseline in Corneal Staining Score on a 6-Point Scale | Baseline, 60 Months |
| Mission Hills |
| California |
| 91345 |
| United States |
| Milauskas Eye Institute | Rancho Mirage | California | 92270 | United States |
| Eye Center of Northern Colorado | Fort Collins | Colorado | 80525 | United States |
| Cape Coral Eye Center, PA | Cape Coral | Florida | 33904 | United States |
| The Eye Institute of West Florida | Largo | Florida | 33770 | United States |
| The Wilmer Eye Institute Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
| Minnesota Eye Consultants, P.A. | Bloomington | Minnesota | 55431 | United States |
| Mulqueeny Eye Centers | Creve Coeur | Missouri | 63141 | United States |
| Mercy Eye Specilaists | Springfield | Missouri | 65804 | United States |
| Cleveland Eye Clinic | Brecksville | Ohio | 44141 | United States |
| Ophthalmic Partners Bala | Cynwyd | Pennsylvania | 19004 | United States |
| Hazleton Eye Specialists | Township | Pennsylvania | 16066 | United States |
| Vanderbilt Eye Institute | Nashville | Tennessee | 37232 | United States |
| Alkek Eye Center, Department of Ophthalmology | Houston | Texas | 77030 | United States |
| The Eye Clinic of Texas/ dba Texas Clinical Eye Research Center | League City | Texas | 77573 | United States |
| See Clearly Vision Group | McLean | Virginia | 22102 | United States |
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D065346 | Lubricant Eye Drops |
| ID | Term |
|---|---|
| D009883 | Ophthalmic Solutions |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D054327 | Lubricants |
| D020313 | Specialty Uses of Chemicals |
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