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
| Name | Class |
|---|---|
| MacuSight, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine the safety and efficacy of an ocular sirolimus (rapamycin) formulation compared to Placebo on the signs and symptoms of dry eye in the CAE Model.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Group 1 | Experimental |
| |
| Dose Group 2 | Experimental |
| |
| Dose Group 3 | Experimental |
| |
| Dose Group 4 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sirolimus | Drug | Subconjunctival injection of 440 micrograms sirolimus in each eye. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean corneal fluorescein staining (inferior region) after CAE exposure. | Day 28 | |
| Mean ocular discomfort during CAE exposure. | Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety across treatment groups. | Through 28 days | |
| Additional evaluations of dry eye including fluorescein staining, lissamine green staining, conjunctival redness, tear film break-up time, blink rate, ocular protection index, Schirmer's Test, and corneal sensitivity. |
Not provided
Inclusion Criteria include, but are not limited to:
Exclusion Criteria include, but are not limited to:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Joel Naor, MD | MacuSight, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ophthalmic Research Associates | Andover | Massachusetts | 01810 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 14, 2017 | |
| Reset | May 19, 2017 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Sirolimus | Drug | Subconjunctival injection of 220 micrograms sirolimus in each eye. |
|
|
| Sirolimus | Drug | Subconjunctival injection of 880 micrograms sirolimus in each eye. |
|
|
| Sirolimus | Drug | Subconjunctival injection of placebo in each eye. |
|
| Day 28 |
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 14, 2017 | May 19, 2017 |
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
Not provided
Not provided