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Evaluate the Safety and Efficacy of the Second Generation Travoprost Intracameral Implant
Evaluate the Safety and Efficacy of the Second Generation Travoprost Intracameral Implant Compared to Timolol Ophthalmic Solution 0.5% Administered Twice Daily in Subjects with Open-Angle Glaucoma or Ocular Hypertension
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
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| 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 |
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| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gen 2 Travoprost Intracameral Implant | Drug | Travoprost |
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| Measure | Description | Time Frame |
|---|---|---|
| Intraocular pressure (IOP) | 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 | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Contact | 949-739-8749 | ClinicalResearch@glaukos.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glaukos Investigative Site | Recruiting | Dothan | Alabama | 36301 | 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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Subjects will be randomized to undergo initial implant of an intracameral implant and prescription of artificial tears or a sham procedure and prescription of timolol. Subjects will be assessed for eligibility for an exchange procedure at 12, 24 or 36 months and followed for an additional 12 months
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The study is double-masked in which treatments will be unknown to the subject and to the site staff performing certain outcome measurements
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| 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 |
|
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| Timolol eye drops 0.5% | Drug | Timolol 0.5% |
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| Sham Procedure | Procedure | Sham implant administration |
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| placebo eye drops | Other | Artificial Tears |
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