Glaucoma, Open-AnglePhase 4NCT06066645
Travoprost Intraocular Implant + iStent Infinite
A Phase 4 study testing Travoprost Intraocular Implant and iStent infinite in people with Glaucoma, Open-Angle, run by Glaukos Corporation at 1 site in United States.
Trial summary
Adult subjects with elevated intraocular pressure will be randomized to receive iStent infinite trabecular bypass system plus a travoprost intraocular implant or receive a sham procedure plus a travoprost intraocular implant and be followed for 12 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Open-Angle
- What is being tested?
- Travoprost Intraocular Implant and iStent infinite
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2023to Feb 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of open-angle glaucoma or ocular hypertension
- qualifying IOP in the study eye
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Glaukos Clinical Study Site
Oklahoma City, Oklahoma, 73112
Study Director, 949-739-8749, idoseclinical@Glaukos.com
About this study
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
Adult subjects with elevated intraocular pressure will be randomized to receive iStent infinite trabecular bypass system plus a travoprost intraocular implant or receive a sham procedure plus a travoprost intraocular implant and be followed for 12 months.
- Conditions
- Glaucoma, Open-Angle
- Being tested
- Travoprost Intraocular Implant, iStent infinite, Sham procedure
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Travoprost Intraocular ImplantDrug
Also called iDose TR
anchored intracameral implant containing travoprost
iStent infiniteDevice
Successful iStent infinite surgery
Sham procedureOther
Sham procedure (to mimic placement of an iStent infinite)
| Study group | Role | What they receive |
|---|---|---|
| iDose TR | Experimental | Travoprost Intraocular Implant in subjects who had successful iStent infinite placement Receives: Drug: Travoprost Intraocular Implant; Device: iStent infinite |
| iDose TR alone | Active comparator | Travoprost Intraocular Implant Receives: Drug: Travoprost Intraocular Implant; Other: Sham procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline in mean diurnal intraocular pressure (IOP)
mean diurnal IOP at the 3 month visit minus mean diurnal IOP at baseline
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start14 Sep 2023
- Primary completionMay 2027 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma, Open-AngleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Glaukos Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Glaukos Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06066645
- Sponsor's protocol ID
- GLK-101-01
- Status last verified
- May 2026
- First submitted
- 27 Sep 2023
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06066645
- Acronym / sponsor ID
- GLK-101-01
- Conditions
- Glaucoma, Open-Angle
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Glaukos CorporationIndustry (pharma, biotech, devices)
- Study start
- 14 Sep 2023 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 4 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Adult subjects with elevated intraocular pressure will be randomized to receive iStent infinite trabecular bypass system plus a travoprost intraocular implant or receive a sham procedure plus a travoprost intraocular implant and be followed for 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iDose TR | Experimental | Drug: Travoprost Intraocular Implant, Device: iStent infiniteTravoprost Intraocular Implant in subjects who had successful iStent infinite placement |
| iDose TR alone | Active comparator | Drug: Travoprost Intraocular Implant, Other: Sham procedureTravoprost Intraocular Implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- diagnosis of open-angle glaucoma or ocular hypertension
- qualifying IOP in the study eye
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Travoprost Intraocular ImplantAlso: iDose TRanchored intracameral implant containing travoprost | Drug | iDose TR, iDose TR alone |
| iStent infiniteSuccessful iStent infinite surgery | Device | iDose TR |
| Sham procedureSham procedure (to mimic placement of an iStent infinite) | Other | iDose TR alone |
Primary outcome
change from baseline in mean diurnal intraocular pressure (IOP)
Time frame: 3 months
mean diurnal IOP at the 3 month visit minus mean diurnal IOP at baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Study Director study director
Glaukos Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Travoprost Intraocular Implant and iStent infinite in people with Glaucoma, Open-Angle, run by Glaukos Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Director (949-739-8749, idoseclinical@glaukos.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline in mean diurnal intraocular pressure (IOP) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.