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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XG-102 | Experimental | sterile ophthalmic solution for sub-conjunctival injection |
|
| placebo | Placebo Comparator | sterile ophthalmic solution for sub-conjunctival injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XG-102 | Drug | Comparison of XG-102 versus placebo for the treatment of ocular inflammation and pain associated with cataract surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Absence of anterior chamber cells | Day 15 | |
| Pain scores as measured by the visual analog scale | Day2 |
| Measure | Description | Time Frame |
|---|---|---|
| Use of rescue medication | up to D22 | |
| Number of patients with adverse events | up to D22 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juli Chalifour | ORA, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ora | Andover | Massachusetts | 01810 | United States |
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| 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 |
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| ID | Term |
|---|---|
| C478085 | D-JNKI-1 |
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| Placebo | Drug | Comparison of XG-102 versus placebo for the treatment of ocular inflammation and pain associated with cataract surgery |
|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |