Travoprost Implant for Glaucoma

Overseen By Study Director

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Glaukos Corporation

Disqualifiers: Prior glaucoma surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 36 months

510 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Evaluate the Safety and Efficacy of the Second Generation Travoprost Intracameral Implant

Are You a Good Fit for This Trial?

Inclusion Criteria

I have ocular hypertension or open-angle glaucoma in my study eye.

Exclusion Criteria

I have had glaucoma surgery in the eye being studied.

I have had argon laser trabeculoplasty in my study eye.

I have had minimally invasive glaucoma surgery in my study eye.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the second generation travoprost intracameral implant or timolol 0.5% eye drops

36 months

Monthly visits for monitoring and exchange procedures at specified months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Gen 2 Travoprost Intracameral Implant

How Is the Trial Designed?

Group I: Cohort Z Gen 2 Travoprost Intracameral Implant Arm Experimental Treatment 2 Interventions

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

Group II: Cohort X Gen 2 Travoprost Intracameral Implant Arm Experimental Treatment 2 Interventions

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

Group III: Cohort Z Timolol Arm Active Control 2 Interventions

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

Group IV: Cohort X Timolol Arm Active Control 2 Interventions

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

Group V: Cohort Y Gen 2 Travoprost Intracameral Implant Arm Active Control 2 Interventions

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

Group VI: Cohort Y Timolol Arm Active Control 2 Interventions

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

Who Is Running the Clinical Trial?

Glaukos Corporation

Lead Sponsor

Trials

69

Recruited

9,500+

Thomas Burns

Glaukos Corporation

Chief Executive Officer since 2002

B.A. from Yale University

Dr. Tomas Navratil

Glaukos Corporation

Chief Medical Officer since 2022

MD from Harvard Medical School