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The primary purpose of this study is to assess the efficacy, tolerability and safety of RX-10045 Ophthalmic Solution in patients with Dry Eye Disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RX-10045 active arm | Experimental | RX-10045 Opththalmic Solution, 0.09% |
|
| Vehicle for RX-10045 arm | Placebo Comparator | Vehicle of RX-10045 Ophthalmic Solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RX-10045 | Drug | One drop of RX-10045 ophthalmic solution will be instilled in each eye, twice a day, approximately 12 hours apart for 28 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Corneal staining | Baseline to day 28 | |
| Worst symptom score | Baseline to day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular discomfort symptom score | Baseline to day 28 | |
| Tear film break-up time | Baseline to day 28 | |
| Visual-related function subscale of Ocular Surface Disease Index score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gail Torkildsen, MD | Andover Eye Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Andover Eye Associates | Andover | Massachusetts | 01810 | 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 |
|---|---|
| C000603302 | isopropyl 5,12-hydroxypentadeca-8,10-dien-6,14-diynoate |
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| Vehicle for RX-10045 | Drug | One drop of RX-10045 placebo solution will be instilled in each eye, twice a day, approximately 12 hours apart for 28 days. |
|
| Baseline to day 28 |