Comparison of Travoprost Implant with iStent Infinite vs. iStent Infinite Alone for Glaucoma
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 vs. iStent Infinite Alone in Subjects With Open-angle Glaucoma or Ocular Hypertension
PHASE3 · Glaukos Corporation · NCT06066645
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 | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 230 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Glaukos Corporation (industry) |
| Locations | 1 site (Colorado Springs, Colorado) |
| Trial ID | NCT06066645 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with unmedicated intraocular pressure exceeding 36 mmHg, significant ocular disease, or poor visual acuity may not benefit from this study.
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 performed: Other studies have shown promising results with similar approaches in managing glaucoma, indicating potential for success in this trial.
Eligibility criteria
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 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 this trial is running
Colorado Springs, Colorado
- Glaukos Clinical Study Site — Colorado Springs, Colorado, United States (RECRUITING)
Study contacts
- Study coordinator: Study Director
- Email: idoseclinical@glaukos.com
- Phone: 949-739-8749
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Glaucoma, Open-Angle