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| Name | Class |
|---|---|
| Alcon Research | INDUSTRY |
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This is a prospective, randomized, double-masked, multi-site clinical trial designed to compare the efficacy of SYSTANE® PRO (Alcon Laboratories, Inc.) to MIEBO™ (Bausch + Lomb) in treating symptoms of evaporative dry eye disease (DED). The primary goal is to determine whether SYSTANE® PRO is non-inferior to MIEBO™ after one month of treatment, based on change in Ocular Surface Disease Index (OSDI) scores.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SYSTANE® PRO | Active Comparator | SYSTANE® PRO is a preservative free artificial tear with a unique triple action formula that contains hyaluronate, nano-sized lipids, and HP-Guar. |
|
| MIEBO™ (Perfluorohexyloctane, PFHO) | Active Comparator | Perfluorohexyloctane (PFHO) ophthalmic solution, which is marketed in the United States as MIEBO™ (Bausch + Lomb; Rochester, NY, USA) is a preservative-free eye drop. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SYSTANE® PRO | Drug | SYSTANE® PRO is a preservative free artificial tear with a unique triple action formula that contains hyaluronate, nano-sized lipids, and HP-Guar. |
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| Measure | Description | Time Frame |
|---|---|---|
| OSDI Scores | Between-group difference in mean change from baseline in Ocular Surface Disease Index (OSDI) Scores at the 1-month visit (0-100 scale). | Between group difference at 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anna Tichenor, OD, PhD, FAAO | Contact | 812-855-0520 | annatich@iu.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye Research Foundation | Recruiting | Newport Beach | California | 92663 | United States |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C118616 | perfluorohexyl-octan |
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| MIEBO™ (Perfluorohexyloctane, PFHO) | Drug | Perfluorohexyloctane (PFHO) ophthalmic solution, which is marketed in the United States as MIEBO™ (Bausch + Lomb; Rochester, NY, USA) is a preservative-free eye drop. |
|
| Indiana Universtiy School of Optometry | Recruiting | Bloomington | Indiana | 47408 | United States |
| Kannarr Eye Care | Recruiting | Pittsburg | Kansas | 66762 | United States |
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| Southern College of Optometry | Recruiting | Memphis | Tennessee | 38104 | United States |
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