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This trial will evaluate the safety and IOP -lowering efficacy of administering an iDose TR (travoprost intracameral implant) in conjunction with cataract surgery compared to cataract surgery alone
This is a Phase 4 randomized, double-masked, parallel group trial designed to evaluate the safety and IOP-lowering efficacy of administering iDose TR (travoprost intracameral implant 75 mcg) in conjunction with uncomplicated cataract surgery (phacoemulsification with a posterior chamber intraocular lens) compared to uncomplicated cataract surgery alone, in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iDose TR (travoprost intracameral implant) 75 µg in conjunction with cataract surgery | Active Comparator | iDose TR (travoprost intracameral implant) 75 µg in conjunction with cataract surgery |
|
| Sham procedure in conjunction with cataract surgery | Sham Comparator | Sham procedure in conjunction with cataract surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iDose TR (travoprost intracameral implant) 75 µg in conjunction with cataract surgery | Combination Product | iDose TR (travoprost intracameral implant) 75 µg in conjunction with cataract surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in mean diurnal IOP | Mean diurnal IOP at the Month 3 Visit minus mean diurnal IOP at the Baseline Visit | 3 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Manager | Contact | 949-739-8749 | ClinicalResearch@glaukos.com |
| Name | Affiliation | Role |
|---|---|---|
| Study Director | Glaukos Corporation | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glaukos Investigator Site | Recruiting | Kenosha | Wisconsin | 53142 | United States |
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| Sham procedure in conjunction with cataract surgery | Procedure | Sham procedure in conjunction with cataract surgery |
|
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D002387 | Cataract Extraction |
| ID | Term |
|---|---|
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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