Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03868124 | Clinical Study Comparing Two Models of a Travoprost Intraocular Implant | PHASE3 | COMPLETED | 560 | — | — | Sep 17, 2018 | Jun 19, 2024 | Nov 29, 2024 | 1 | United States |
| NCT03519386 | Randomized Study Comparing Two Models of a Travoprost Intraocular Implant to Timolol Maleate Ophthalmic Solution, 0.5% | PHASE3 | COMPLETED | 590 | — | — | Jul 26, 2018 | Apr 2, 2024 | Nov 29, 2024 | 1 | United States |
Change from time-matched baseline in IOP at 8AM and 10AM at Day 10, Week 6 and Month 3. Day 10 8AM IOP minus Baseline 8AM IOP; Day 10 10AM IOP minus Baseline 10AM IOP; Week 6 8AM IOP minus Baseline 8AM IOP; Week 6 10AM IOP minus Baseline 10AM IOP; Month 3 8AM IOP minus Baseline 8AM IOP; Month 3 10AM IOP minus Baseline 10AM IOP.
| Arm | Type | Description |
|---|---|---|
| Implant Group 1 | EXPERIMENTAL | G2-TR intraocular implant containing Travoprost 75 mcg with high elution rate, plus postoperative placebo eye drops. |
| Implant Group 2 | EXPERIMENTAL | G2-TR intraocular implant containing Travoprost 75 mcg with low elution rate, plus postoperative placebo eye drops. |
| Control Group | ACTIVE_COMPARATOR | Sham surgery + active-comparator eye drops |
| Name | Type | Description |
|---|---|---|
| G2-TR intraocular implant containing travoprost | COMBINATION_PRODUCT | Provided in Arm/Group descriptions |
| Sham surgery + active-comparator eye drops | DRUG | Sham surgery plus postoperative active-comparator eye drops (Timolol Maleate ophthalmic solution, 0.5%) |
Inclusion Criteria: * Diagnosed with open-angle glaucoma or ocular hypertension * C/D ratio ≤ 0.8 * Zero to two preoperative ocular hypotensive medications Exclusion Criteria: * Active corneal inflammation or edema * Retinal disorders not associated with glaucoma