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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07495852 | Trial to Evaluate the Safety and Efficacy of the Second Generation Travoprost Intracameral Implant | PHASE3 | RECRUITING | 510 | — | — | Feb 17, 2026 | Mar 1, 2032 | Mar 30, 2026 | 1 | United States |
| NCT07075718 | Phase 2/Phase 3 Trial to Evaluate the Safety and Efficacy of the Second Generation Travoprost Intracameral Implant | PHASE2 | RECRUITING | 610 | — | — | Jun 12, 2025 | Mar 1, 2032 | Mar 2, 2026 | 3 | United States |
Change from baseline in diurnal IOP in the study eye at 8am and 10am at each of Day 11, Week 6, and Month 3 visits
| Arm | Type | Description |
|---|---|---|
| Cohort X Gen 2 Travoprost Intracameral Implant Arm | EXPERIMENTAL | Randomized, double-masked, active-controlled, Phase 3 portion of the trial; subjects will receive second generation travoprost intracameral implant (plus placebo eyedrops BID) in the study eye and undergo an exchange procedure at month 12 and be followed for an additional 12 months |
| Cohort X Timolol Arm | ACTIVE_COMPARATOR | Randomized, double-masked, active-controlled, Phase 3 portion of the trial; subjects will administer timolol 0.5% eye drops BID (plus sham procedure) in the study eye and undergo a sham exchange procedure at month 12 and be followed for an additional 12 months |
| Cohort Y Gen 2 Travoprost Intracameral Implant Arm | ACTIVE_COMPARATOR | Randomized, double-masked, active-controlled, Phase 3 portion of the trial, subjects will receive second generation travoprost intracameral implant (plus placebo eyedrops BID) in the study eye and undergo an exchange procedure at month 24 and be followed for an additional 12 months |
| Cohort Y Timolol Arm | ACTIVE_COMPARATOR | Randomized, double-masked, active-controlled, Phase 3 portion of the trial; subjects will receive timolol 0.5% eye drops BID (plus sham procedure) in the study eye and undergo a sham exchange procedure at month 24 and be followed for an additional 12 months |
| Cohort Z Gen 2 Travoprost Intracameral Implant Arm | EXPERIMENTAL | Randomized, double-masked, active-controlled, Phase 3 portion of the trial, subjects will receive second generation travoprost intracameral implant (plus placebo eyedrops BID) in the study eye and undergo an exchange procedure at month 36 and be followed for an additional 12 months |
| Cohort Z Timolol Arm | ACTIVE_COMPARATOR | Randomized, double-masked, active-controlled, Phase 3 portion of the trial; subjects will administer timolol 0.5% eye drops BID (plus sham procedure) in the study eye and undergo an sham exchange procedure at month 36 and be followed for an additional 12 months |
| Period 1 (Cohort A) | EXPERIMENTAL | Single-arm, open-label portion of Phase 2; subjects will receive second generation travoprost intracameral implant (plus placebo eyedrops BID) in the study eye and be followed for 36 months |
| Period 2 (Cohort B) Gen 2 Travoprost Intracameral Implant Arm | EXPERIMENTAL | Randomized, double-masked, active-controlled Phase 2 portion of the trial; subjects will receive second generation travoprost intracameral implant (plus placebo eyedrops BID) in the study eye and be followed for 36 months |
| Period 2 (Cohort B) Timolol Arm | ACTIVE_COMPARATOR | Randomized, double-masked, active-controlled, Phase 2 portion of the trial; subjects will administer timolol 0.5% eye drops BID (plus sham procedure) in the study eye and be followed for 36 months |
| Period 3 (Cohort X) Gen 2 Travoprost Intracameral Implant Arm | EXPERIMENTAL | Randomized, double-masked, active-controlled, Phase 3 portion of the trial; subjects will receive second generation travoprost intracameral implant (plus placebo eyedrops BID) in the study eye and undergo an exchange procedure at month 12 and be followed for an additional 12 months |
| Period 3 (Cohort X) Timolol Arm | ACTIVE_COMPARATOR | Randomized, double-masked, active-controlled, Phase 3 portion of the trial; subjects will administer timolol 0.5% eye drops BID (plus sham procedure) in the study eye and undergo a sham exchange procedure at month 12 and be followed for an additional 12 months |
| Period 3 (Cohort Y) Gen 2 Travoprost Intracameral Implant Arm | ACTIVE_COMPARATOR | Randomized, double-masked, active-controlled, Phase 3 portion of the trial, subjects will receive second generation travoprost intracameral implant (plus placebo eyedrops BID) in the study eye and undergo an exchange procedure at month 24 and be followed for an additional 12 months |
| Period 3 (Cohort Y) Timolol Arm | ACTIVE_COMPARATOR | Randomized, double-masked, active-controlled, Phase 3 portion of the trial; subjects will receive timolol 0.5% eye drops BID (plus sham procedure) in the study eye and undergo a sham exchange procedure at month 24 and be followed for an additional 12 months |
| Period 3 (Cohort Z) Gen 2 Travoprost Intracameral Implant Arm | EXPERIMENTAL | Randomized, double-masked, active-controlled, Phase 3 portion of the trial, subjects will receive second generation travoprost intracameral implant (plus placebo eyedrops BID) in the study eye and undergo an exchange procedure at month 36 and be followed for an additional 12 months |
| Period 3 (Cohort Z) Timolol Arm | ACTIVE_COMPARATOR | Randomized, double-masked, active-controlled, Phase 3 portion of the trial; subjects will administer timolol 0.5% eye drops BID (plus sham procedure) in the study eye and undergo an sham exchange procedure at month 36 and be followed for an additional 12 months |
| Name | Type | Description |
|---|---|---|
| Gen 2 Travoprost Intracameral Implant | DRUG | Travoprost |
| Timolol eye drops 0.5% | DRUG | Timolol 0.5% |
| Sham Procedure | PROCEDURE | Sham implant administration |
| placebo eye drops | OTHER | Artificial Tears |
Inclusion Criteria: * Diagnosis of Ocular Hypertension or Open-Angle Glaucoma in the study eye Exclusion Criteria: * Prior incisional glaucoma surgery in the study eye * Prior argon laser trabeculoplasty (ALT) in the study eye * Prior minimally invasive glaucoma (MIGS) surgery in the study eye