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The purpose of this study is to assess the safety and efficacy of Tavilermide Ophthalmic Solution compared with Placebo Ophthalmic Solution in treating the signs and symptoms of dry eye disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tavilermide Ophthalmic Solution | Active Comparator | 1% Tavilermide Ophthalmic Solution |
|
| Vehicle Ophthalmic Solution | Placebo Comparator | Placebo Ophthalmic Solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1% Tavilermide Ophthalmic Solution | Drug | 1% Tavilermide BID Dosing |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Total Corneal Fluorescein Staining Using The Ora Calibra Scale | An assessment of the total corneal fluorescein staining using the Ora Calibra Scale both immediately prior to and immediately following exposure to a challenge in a controlled adverse environment (CAE) | Day 57 |
| Ocular Discomfort Using The Ora Calibra Scale | A patient-reported subjective assessment of ocular discomfort recorded at each of the 5 office visits throughout the treatment period | Day 57 |
| Measure | Description | Time Frame |
|---|---|---|
| Total Corneal Fluorescein Staining Using The Ora Calibra Scale | An assessment of the total corneal fluorescein staining using the Ora Calibra Scale both immediately prior to and immediately following exposure to a challenge in a controlled adverse environment (CAE) | Day 15 |
| Ocular Surface Disease Index |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Garth Cumberlidge, PhD | Mimetogen Pharmaceuticals USA, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MIM-726 Investigational Site | Torrance | California | United States |
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| ID | Term |
|---|---|
| D007638 | Keratoconjunctivitis Sicca |
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007637 | Keratoconjunctivitis |
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
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| Placebo Ophthalmic Solution |
| Drug |
Vehicle Ophthalmic Solution |
|
| Day 57 |
| Ocular Dryness Using The Ora Calibra Scale | A patient-reported subjective assessment of ocular dryness recorded twice daily over the complete treatment period. | 8 weeks |
| D007634 |
| Keratitis |
| D003316 | Corneal Diseases |
| D007766 | Lacrimal Apparatus Diseases |