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 evaluate the clinical efficacy and safety of XG-102 (900µg) compared to vehicle in the treatment of subjects with inflammation and pain following cataract surgery.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XG-102 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XG-102 | Drug | Comparison of XG-102 versus placebo sub-conjunctival injection efficacy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Absence of anterior chamber cells for the 900µg XG-102 sub-conjunctival injection compared to vehicle | Day 15 | |
| Absence of pain for the 900µg XG-102 compared to vehicle | Day2 |
| Measure | Description | Time Frame |
|---|---|---|
| Use of rescue medication | up to Day 85 |
| Measure | Description | Time Frame |
|---|---|---|
| Specular microscopy | Day 85 | |
| Adverse event (AE) monitoring | up to Day 85 |
Key Inclusion Criteria:
Key Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Steven M Silverstein, MD | Silverstein Eye Centers | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Garden Grove | California | 92843 | United States |
Not provided
| ID | Term |
|---|---|
| D007249 | Inflammation |
| D010146 | Pain |
| D002386 | Cataract |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C478085 | D-JNKI-1 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Drug |
comparison of XG-102 versus placebo sub-conjunctival injection efficacy |
|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |