Cataract in Inflammatory Ocular Disorders Clinical Trial
Official title:
A Phase 2 Clinical Study to Assess the Efficacy and Safety of SED80 for the Treatment of Inflammation and Pain Associated With Cataract Surgery
| Verified date | September 2020 |
| Source | iDrop, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Patients at least 40 years of age who are undergoing cataract surgery will be randomized to receive treatment with one of four groups of dexamethasone ophthalmic suspension or placebo eye drops to determine if the drops decrease inflammation and pain inside the eye and are safe after cataract surgery.
| Status | Completed |
| Enrollment | 60 |
| Est. completion date | November 15, 2020 |
| Est. primary completion date | October 31, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 40 Years and older |
| Eligibility | Inclusion Criteria: - Patients undergoing traditional cataract surgery. Exclusion Criteria: - Patients with unusual ocular conditions. |
| Country | Name | City | State |
|---|---|---|---|
| El Salvador | Centre De. Oftalmologia | San Salvador |
| Lead Sponsor | Collaborator |
|---|---|
| iDrop, Inc. |
El Salvador,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Ocular inflammation | Measuring Anterior Cell Count | Day 8 | |
| Secondary | Ocular Pain | Measuring patient ocular pain using an 11-point visual scale | Day 8 |