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| Name | Class |
|---|---|
| AbbVie | INDUSTRY |
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The objective of this study is to evaluate whether reduction in topical medication with the injection of a sustained release capsule (Durysta) leads to a reduction in ocular surface inflammation, indicated by levels of caspase-1, an inflammatory biomarker.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Durysta | Experimental | Participants will receive a one-time intracameral administration of Durysta - bimatoprost 10mcg |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Durysta, Bimatoprost Intracameral Implant 10 µg | Drug | Participants in this arm will receive a one-time injection of Durysta (intracameral bimatoprost 10mcg). Participants will be followed by a total of 3 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Caspase-1 mRNA Expression Following Durysta Injection | The primary outcome is evaluating whether the level of caspase-1 from the ocular surface changes after the Durysta injection when the number of topical medications is reduced. Higher values indicate more inflammation, while lower values indicate less information and a more stable ocular surface. The Caspase-1 level will be measured using RT-PCR. | Baseline, post-injection 1 month, post-injection 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Corneal Sensitivity Following Durysta Injection | Change in corneal tactile sensitivity from measured using a non-contact esthesiometer (in sensitivity units). Greater sensitivity values indicate less ocular surface dysfunction; lower values reflect reduced sensitivity and potential surface. | Baseline, post-injection 1 month, post-injection 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Javier Paredes, BA, MBA | Contact | 305-326-6387 | jxp2537@med.miami.edu | |
| Monica Arango, BA | Contact | 305-326-6351 | mrarango@med.miami.edu |
| Name | Affiliation | Role |
|---|---|---|
| Swarup S Swaminathan, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bascom Palmer Eye Institute | Recruiting | Miami | Florida | 33134 | United States |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| Change in Ocular Pain Symptoms via Visual Analog Scale (VAS) | Change in patient-reported ocular pain symptoms from post-Durysta injection, assessed using a Visual Analog Scale (VAS). VAS scores range from 1 to 10, where higher scores indicate more severe pain and lower scores reflect minimal discomfort. | Baseline, post-injection 1 month, post-injection 3 months |
| Change in Corneal Staining Score Using the National Eye Institute (NEI) Grading System | Change in corneal staining score post-Durysta injection, assessed using the National Eye Institute (NEI) grading system. This system evaluates five corneal regions-central, temporal, superior, nasal, and inferior-with each region scored from 0 to 3 based on fluorescein staining intensity. The total score ranges from 0 (no staining) to 15 (diffuse staining across all regions). Lower scores indicate improved ocular surface integrity and reduced epithelial damage; higher scores reflect more extensive surface compromise. | Baseline, post-injection 1 month, post-injection 3 months |