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This is a phase III, prospective, randomised, double-masked, placebo-controlled, parallel-design, multicenter study of the efficacy, safety and pharmacokinetics of 9% dexamethasone intraocular injection for the treatment of inflammation associated with cataract surgery.
This is a prospective, randomized, double-blindmasked, placebo-controlled, parallel- design, multicenter study of subjects over 40 years undergoing cataract surgery. Subjects meet the inclusion criteria and do not meet any exclusion criteria are randomiszed to the dexamethasone implant group or placebo group at a ratio of 2:1.
Subjects received a single does injection in the study eye immediately after the completion of cataract surgery. The investigational drug comes with a special injection device and injection guide.
All subjects will be administered to the study eye with quinolone topical antibiotic eye drops or their equivalent 3 days before and 7 days after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexamethasone intraocular injection | Experimental | Dexamethasone implant single injection in the treatment eye after cataract surgery. |
|
| Placebo | Placebo Comparator | Blank placebo single injection in the treatment eye after cataract surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexycu | Drug | 5ul dexamethasone, concentration: 103.4 μg/μl, equivalent to 517μg dexamethasone |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anterior chamber cell clearing rate | The primary efficacy outcome is anterior chamber cell clearing in the study eye at Day 8. The slit lamp examination for anterior chamber cells (ACC) is a recognized way to measure inflammation in the anterior chamber. During the slit lamp examination, the number of anterior chamber cells are quantified and graded: grade 0 (absent, 0 cells), grade 1 (1 to 5 cells), grade 2 (6 to 15 cells), grade 3 (16 to 30+ cells), or grade 4 (hypopyon). Anterior chamber cell clearing occurs when all the ACC are absent (grade 0). | DAY 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Anterior chamber cell clearing rates | The secondary efficacy outcome is anterior chamber cell clearing in the study eye at Day 1 & 3 & 15 & 30. The slit lamp examination for anterior chamber cells (ACC) is a recognized way to measure inflammation in the anterior chamber. During the slit lamp examination, the number of anterior chamber cells are quantified and graded: grade 0 (absent, 0 cells), grade 1 (1 to 5 cells), grade 2 (6 to 15 cells), grade 3 (16 to 30+ cells), or grade 4 (hypopyon). Anterior chamber cell clearing occurs when all the ACC are absent (grade 0). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhixun Li | Ocumension Therapeutics (Shanghai) Co., Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai General Hospital | Shanghai | China |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| D002386 | Cataract |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D002123 | Calcium Dobesilate |
| ID | Term |
|---|---|
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Placebo | Drug | Acetyl triethyl citrate |
|
| DAY 1 & 3 & 15 & 30 |
| Anterior chamber flare clearing rates | Percentage of subjects with anterior chamber flare grade 0 at Day 1, 3, 8, 15, and 30. The slit lamp examination for anterior chamber flare (ACF) is a recognized way to measure inflammation in the anterior chamber. During the slit lamp examination, the number of anterior chamber cells are quantified and graded: grade 0 (absent), grade 1 (trace), grade 2 (mild intensity), grade 3 (moderate intensity), or grade 4 (strong intensity). Anterior chamber flare clearing occurs when all the ACC are absent (grade 0). | DAY 1 & 3 & 8 & 15 & 30 |
| Anterior chamber cell & flare clearing rates | The secondary efficacy outcome is anterior chamber cell & flare clearing in the study eye at Day 1 & 3 & 15 & 30. The slit lamp examination for anterior chamber cells & flare (ACCF) is a recognized way to measure inflammation in the anterior chamber. | DAY 1 & 3 & 15 & 30 |
| Mean anterior chamber cell score and mean anterior chamber flare score | Calculate the mean score of anterior chamber cell and flare separately at Day 8 and 15. | DAY 8 & 15 |
| Mean anterior chamber cell + flare score | Calculate the mean socre of anterior chamber cell + flare at Day 8 and 15. | DAY 8 &15 |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |