Glaucoma, Open-anglePhase 4NCT06848946
Safety and Efficacy of iDose® TR With Cataract Surgery vs. Cataract Surgery Alone
A Phase 4 study testing iDose TR (travoprost intracameral implant) 75 µg in conjunction with cataract surgery in people with Glaucoma, Open-angle and Ocular Hypertension (OHT), run by Glaukos Corporation at 1 site in United States.
Trial summary
This trial will evaluate the safety and IOP -lowering efficacy of administering an iDose TR (travoprost intracameral implant) in conjunction with cataract surgery compared to cataract surgery alone Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Glaucoma, Open-angle, Ocular Hypertension (OHT), Phacoemulsification Cataract Surgery
- What is being tested?
- iDose TR (travoprost intracameral implant) 75 µg in conjunction with cataract surgery
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2025to Jun 2027
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cataract diagnosis: clinically significant age-related cataract eligible for phacoemulsification in the study eye.
- OAG or OHT diagnosis: either OAG (i.e. primary, pseudoexfoliation, or pigmentary glaucoma) or OHT in the study eye (i.e., eye to undergo cataract surgery)
Who cannot join
- Active corneal inflammation or edema.
- Retinal disorders not associated with glaucoma.
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 Investigator Site
Kenosha, Wisconsin, 53142
idose@glaukos.com
About this study
Official title: Multicenter, Randomized, Double-masked, Parallel Group Trial to Evaluate the Safety and Efficacy of iDose® TR (Travoprost Intracameral Implant) in Conjunction With Cataract Surgery vs. Cataract Surgery Alone
This trial will evaluate the safety and IOP -lowering efficacy of administering an iDose TR (travoprost intracameral implant) in conjunction with cataract surgery compared to cataract surgery alone
Read the detailed description
This is a Phase 4 randomized, double-masked, parallel group trial designed to evaluate the safety and IOP-lowering efficacy of administering iDose TR (travoprost intracameral implant 75 mcg) in conjunction with uncomplicated cataract surgery (phacoemulsification with a posterior chamber intraocular lens) compared to uncomplicated cataract surgery alone, in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).
- Being tested
- iDose TR (travoprost intracameral implant) 75 µg in conjunction with cataract surgery, Sham procedure in conjunction with cataract surgery
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iDose TR (travoprost intracameral implant) 75 µg in conjunction with cataract surgeryCombination product
iDose TR (travoprost intracameral implant) 75 µg in conjunction with cataract surgery
Sham procedure in conjunction with cataract surgeryProcedure or surgery
Sham procedure in conjunction with cataract surgery
| Study group | Role | What they receive |
|---|---|---|
| iDose TR (travoprost intracameral implant) 75 µg in conjunction with cataract surgery | Active comparator | iDose TR (travoprost intracameral implant) 75 µg in conjunction with cataract surgery Receives: Combination Product: iDose TR (travoprost intracameral implant) 75 µg in conjunction with cataract surgery |
| Sham procedure in conjunction with cataract surgery | Sham comparator | Sham procedure in conjunction with cataract surgery Receives: Procedure: Sham procedure in conjunction with cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in mean diurnal IOP
Mean diurnal IOP at the Month 3 Visit minus mean diurnal IOP at the Baseline Visit
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 posted27 Feb 2025
- Study start13 Jan 2025
- Primary completionAug 2026 (estimated)
- Study completionJun 2027 (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.
- More trials run by Glaukos CorporationThe sponsor's other registered studies.
- 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
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Glaukos Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study chair, Glaukos Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06848946
- Sponsor's protocol ID
- GLK-101-04
- Status last verified
- Jan 2026
- First submitted
- 1 Feb 2025
- Last updated
- 21 Jan 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 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Double-masked, Parallel Group Trial to Evaluate the Safety and Efficacy of iDose® TR (Travoprost Intracameral Implant) in Conjunction With Cataract Surgery vs. Cataract Surgery Alone
- ClinicalTrials.gov ID
- NCT06848946
- Acronym / sponsor ID
- GLK-101-04
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Glaukos CorporationIndustry (pharma, biotech, devices)
- Study start
- 13 Jan 2025 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 27 Feb 2025 (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.
This trial will evaluate the safety and IOP -lowering efficacy of administering an iDose TR (travoprost intracameral implant) in conjunction with cataract surgery compared to cataract surgery alone
Detailed description
This is a Phase 4 randomized, double-masked, parallel group trial designed to evaluate the safety and IOP-lowering efficacy of administering iDose TR (travoprost intracameral implant 75 mcg) in conjunction with uncomplicated cataract surgery (phacoemulsification with a posterior chamber intraocular lens) compared to uncomplicated cataract surgery alone, in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).
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 (travoprost intracameral implant) 75 µg in conjunction with cataract surgery | Active comparator | Combination Product: iDose TR (travoprost intracameral implant) 75 µg in conjunction with cataract surgeryiDose TR (travoprost intracameral implant) 75 µg in conjunction with cataract surgery |
| Sham procedure in conjunction with cataract surgery | Sham comparator | Procedure: Sham procedure in conjunction with cataract surgerySham procedure in conjunction with cataract surgery |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Cataract diagnosis: clinically significant age-related cataract eligible for phacoemulsification in the study eye.
- OAG or OHT diagnosis: either OAG (i.e. primary, pseudoexfoliation, or pigmentary glaucoma) or OHT in the study eye (i.e., eye to undergo cataract surgery)
Key exclusion criteria (2 listed)
- Active corneal inflammation or edema.
- Retinal disorders not associated with glaucoma.
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 |
|---|---|---|
| iDose TR (travoprost intracameral implant) 75 µg in conjunction with cataract surgeryiDose TR (travoprost intracameral implant) 75 µg in conjunction with cataract surgery | Combination product | iDose TR (travoprost intracameral implant) 75 µg in conjunction with cataract surgery |
| Sham procedure in conjunction with cataract surgerySham procedure in conjunction with cataract surgery | Procedure or surgery | Sham procedure in conjunction with cataract surgery |
Primary outcome
Change from baseline in mean diurnal IOP
Time frame: 3 Months
Mean diurnal IOP at the Month 3 Visit minus mean diurnal IOP at the Baseline Visit
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 21 Jan 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 chair
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 iDose TR (travoprost intracameral implant) 75 µg in conjunction with cataract surgery in people with Glaucoma, Open-angle and Ocular Hypertension (OHT), 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 2 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 21 Jan 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. Some participants in this study may receive a placebo. 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 Manager (949-739-8749, ClinicalResearch@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 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 21 Jan 2026.