Comparison of Travoprost Implant with iStent Infinite vs. iStent Infinite Alone for Glaucoma
Official title: Multicenter, Randomized, Double-masked Trial to Evaluate the Safety and Efficacy of iDose® TR (Travoprost Intraocular Implant) in Conjunction With the Placement of iStent Infinite in Subjects With Open-angle Glaucoma or Ocular Hypertension
Run by Glaukos Corporation · NCT06066645 · Data updated 2026-11-12
This study tests if combining a new eye implant with the iStent Infinite can lower eye pressure better than using the iStent Infinite alone in adults with glaucoma or high eye pressure.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Glaukos Corporation Industry-sponsored |
| Locations | 1 site (Oklahoma City, Oklahoma) |
| Status | Recruiting |
| Started | September 14, 2023 |
| Main results expected | May 2027 |
| Study ends | February 2028 |
| Registry record updated | June 2, 2026 |
| Trial ID | NCT06066645 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults diagnosed with open-angle glaucoma or ocular hypertension who have previously undergone placement of the iStent Infinite.
✕Probably not a fit
Patients with unmedicated intraocular pressure exceeding 36 mmHg, significant ocular disease, or poor visual acuity may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effectiveness of a travoprost intraocular implant combined with the iStent Infinite trabecular bypass system compared to the iStent Infinite alone in adults with open-angle glaucoma or ocular hypertension. Participants will be randomized to receive either the implant or a sham procedure and will be monitored for 12 months to assess intraocular pressure changes. The study aims to determine if the combination treatment provides superior outcomes in managing elevated intraocular pressure.
Why it matters
Potential benefit: If successful, this approach could lead to improved management of intraocular pressure in patients with glaucoma, potentially preserving vision and enhancing quality of life.
How similar studies have gone: Other studies have shown promising results with similar approaches in managing glaucoma, indicating potential for success in this trial.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * diagnosis of open-angle glaucoma or ocular hypertension * qualifying IOP in the study eye Exclusion Criteria: * unmedicated (washed out) IOP of \>36 mmHg in the study eye * hypersensitivity to travoprost or any other components of the travoprost intraocular implant * vertical cup/disc ratio \> 0.8 in the study eye * best spectacle corrected visual acuity of worse than 20/80 in either eye * any ocular disease or condition that, in the opinion of the investigator, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
Where it's running
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Glaukos Clinical Study Site
Oklahoma City, Oklahoma, United States Recruiting
Study contacts
- Study coordinator: Study Director
- Email: idoseclinical@glaukos.com
- Phone: 949-739-8749
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Slow-coagulation trans-scleral cyclophotocoagulation versus trabeculectomy with mitomycin C for uncontrolled open-angle glaucoma after cataract surgery
This trial will test whether slow-coagulation trans-scleral cyclophotocoagulation or trabeculectomy with mitomycin C better lowers eye pressure in people over 40 with pseudophakic open-angle glaucoma not controlled by medications.
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Virtual reality visual field testing for people with open-angle glaucoma
This will test whether a virtual reality visual field test can match the standard Humphrey Field Analyzer for people with open‑angle glaucoma.
-
Evaluating the safety and effectiveness of iDose TR with cataract surgery
This study is testing if adding the iDose TR implant during cataract surgery can safely lower eye pressure better than just having cataract surgery alone for people with glaucoma or high eye pressure.
-
Electrical stimulation to improve vision in glaucoma
This trial will test whether a noninvasive transorbital alternating current stimulation device (EYETRONIC rtACS) can improve vision in adults with moderate open-angle glaucoma.
-
Comparing Hydrus Microstent and Goniotomy for Glaucoma Treatment
This study is testing whether the Hydrus Microstent works better than goniotomy for lowering eye pressure in people with mild to moderate glaucoma who are also having cataract surgery.
-
Comparing two treatments for glaucoma with cataract
This study is testing whether a new surgery for glaucoma combined with cataract removal works as well as the usual surgery plus eye drops for people with both conditions.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.