510 Participants NeededMy employer runs this trial

Travoprost Implant for Glaucoma

SD
Overseen ByStudy Director
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Glaukos Corporation
No Placebo GroupAll 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 DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines a new treatment for individuals with ocular hypertension (high eye pressure) or open-angle glaucoma. The study tests a second-generation Travoprost implant designed to reduce eye pressure. Participants will receive either this implant or standard eye drops known as Timolol. Those with ocular hypertension or open-angle glaucoma who have not undergone specific types of eye surgeries may qualify for this trial. As a Phase 3 trial, it represents the final step before FDA approval, providing participants an opportunity to contribute to a potentially groundbreaking treatment.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to ask the trial coordinators for more details.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the second-generation travoprost implant, used inside the eye, has generally been well-tolerated in earlier studies. One study found it safe for use during routine cataract surgery, with no serious safety issues reported. Another study demonstrated that the implant effectively lowered eye pressure, crucial for treating glaucoma, without causing major side effects. Some patients experienced minor side effects, but these were usually manageable. Overall, evidence from previous trials suggests that this treatment is safe for humans.12345

Why do researchers think this study treatment might be promising?

Researchers are excited about the Gen 2 Travoprost Intracameral Implant for glaucoma because it offers a novel delivery method compared to traditional eye drops like timolol. This implant releases travoprost, a prostaglandin analog, directly into the eye, potentially improving adherence since patients won't need to remember daily doses. Moreover, the implant could provide more consistent pressure reduction over time, which is crucial for managing glaucoma effectively. In contrast to typical eye drop treatments that require frequent application, this implant could simplify the treatment routine, offering a more convenient and potentially more effective option for patients.

What evidence suggests that this trial's treatments could be effective for glaucoma?

Studies have shown that the Gen 2 Travoprost Intracameral Implant, which participants in this trial may receive, effectively lowers eye pressure. One study found an average reduction of 11 mm Hg in eye pressure after 12 months, with 98% of patients experiencing significant drops. This implant also reduces the need for daily eye drops, providing significant relief for patients. Early results from another study showed impressive pressure reduction in initial patients. Overall, the implant has been well-tolerated and has shown promising results in managing glaucoma.36789

Are You a Good Fit for This Trial?

This trial is for people diagnosed with ocular hypertension or open-angle glaucoma in one eye. You can't join if you've had certain types of glaucoma surgery or laser treatments in that eye before.

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

Trial Overview

The study compares a new Travoprost implant placed inside the eye to standard Timolol eye drops, as well as placebo (inactive) versions of both. The goal is to see how safe and effective the implant is at lowering eye pressure.

How Is the Trial Designed?

6

Treatment groups

Experimental Treatment

Active Control

Group I: Cohort Z Gen 2 Travoprost Intracameral Implant ArmExperimental Treatment2 Interventions
Group II: Cohort X Gen 2 Travoprost Intracameral Implant ArmExperimental Treatment2 Interventions
Group III: Cohort Z Timolol ArmActive Control2 Interventions
Group IV: Cohort X Timolol ArmActive Control2 Interventions
Group V: Cohort Y Gen 2 Travoprost Intracameral Implant ArmActive Control2 Interventions
Group VI: Cohort Y Timolol ArmActive Control2 Interventions

Find a Clinic Near You

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

Citations

Long-Term Safety and Efficacy Evaluation of Travoprost ...

The purpose of this study was to conduct and interpret a pooled 12-month analysis of two prospective, multi-center, randomized, double-masked, controlled trials

Study Details | NCT07495852 | Trial to Evaluate the Safety ...

Evaluate the Safety and Efficacy of the Second Generation Travoprost Intracameral Implant ... Drug : Gen 2 Travoprost Intracameral Implant.

Twelve-Month Outcomes of Standalone Travoprost ...

This retrospective study evaluated real-world outcomes of standalone iDose TR intracameral travoprost implant administration.

Second-generation travoprost intracameral implant shows " ...

So far, the results have shown “impressive” intraocular pressure (IOP) lowering in the first 10 patients. Steve Sarkisian, MD: Hi. I'm Steve ...

Travoprost Intracameral Implant Reduces Glaucoma Drop ...

A sustained-release travoprost intracameral implant significantly reduced the need for topical intraocular pressure (IOP)–lowering ...

Study Details | NCT07075718 | Phase 2/Phase 3 Trial to ...

... Glaucoma or Ocular Hypertension. Official Title. Phase 2/Phase 3 Trial to Evaluate the Safety and Efficacy of the Second Generation Travoprost Intracameral ...

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39959854/

Safety and efficacy of travoprost intracameral implant ...

The study showed that it is safe to combine the placement of the travoprost intracameral implant in the eye during the same procedure as routine cataract ...

Phase 3 Randomized Clinical Trial of the Safety and ...

A 3-year, phase 2 clinical trial demonstrated that both models of the travoprost intraocular implant were well tolerated and reduced topical IOP-lowering ...

Phase 2/Phase 3 Trial to Evaluate the Safety and Efficacy ...

Clinical trial for Glaucoma , Phase 2/Phase 3 Trial to Evaluate the Safety and Efficacy of the Second Generation Travoprost Intracameral ...