Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to assess the safety and efficacy of MIM-D3 Ophthalmic Solution compared with Placebo Ophthalmic Solution in treating the signs and symptoms of dry eye.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1% MIM-D3 | Active Comparator | 1% MIM-D3 Ophthalmic Solution |
|
| Vehicle | Placebo Comparator | Vehicle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MIM-D3 Ophthalmic Solution | Drug | 1% MIM-D3 dosed BID |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Corneal Fluorescein Staining | Day 29 | |
| Ocular Dryness | Patient-derived, daily dryness symptoms for the 28 day time period will be be averaged to obtain a dryness score for the entire 28-day period. Average dryness scores over the 28-day treatment period will be compared between 1% MIM-D3 and placebo using t-tests. | 28 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Total Ocular Fluorescein Staining | Day 29 | |
| Ocular Discomfort | Patient-derived daily diary ocular discomfort symptoms for the 28 day time period will be averaged to obtain an ocular discomfort score for the entire 28-day period. Average ocular discomfort scores over the 28-day treatment period will be compared between 1% MIM-D3 and placebo using t-tests. |
| Measure | Description | Time Frame |
|---|---|---|
| Fluorescein staining (Ora CalibraTM Scale) | Fluorescein Staining, (pre and post-CAESM; by individual region: central, superior, inferior, temporal, nasal, corneal sum, conjunctival sum, and total), by both grade and clearance of staining; | Day 15, 29 and 57 |
| Lissamine green staining (Ora CalibraTM Scale,) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Garth Cumberlidge, PhD | Mimetogen Pharmaceuticals USA, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MIM-725 Investigational Site | Waterbury | Connecticut | 06708 | United States | ||
| MIM-725 Investigational Site |
Not provided
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Vehicle | Drug | Vehicle dosed BID |
|
|
| 28 Days |
Lissamine green staining (pre and post-CAESM; regions: central, superior, inferior, temporal, nasal, corneal sum, conjunctival sum, and total) |
| Day 15, 29 and 57 |
| Subject diary individual symptoms | 28-day and 56-day treatment periods |
| Tear film break-up time | Tear film break-up time (pre and post-CAESM); | Day 15, 29 and 57 |
| Lewiston |
| Maine |
| 04240 |
| United States |
| MIM-725 Investigational Site | Andover | Massachusetts | 01810 | United States |
| MIM-725 Investigational Site | Quincy | Massachusetts | 02169 | United States |
| MIM-725 Investigational Site | Memphis | Tennessee | 38119 | United States |