Open Angle GlaucomaPhase 3NCT06061718
Travoprost Intraocular Implant in Conjunction With Cataract Surgery
A Phase 3 study testing iDose TR in people with Open Angle Glaucoma and Ocular Hypertension, run by Glaukos Corporation at 1 site in Armenia.
Trial summary
Subjects with cataract requiring extraction and who have open-angle glaucoma or ocular hypertension will undergo screening and washout from IOP-lowering medication, if applicable. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Open Angle Glaucoma, Ocular Hypertension
- What is being tested?
- iDose TR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteArmenia
- Study dates
- 11 Sep 2023to 20 Dec 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- clinically significant age-related cataract eligible for phacoemulsification in the study eye
- open-angle glaucoma or ocular hypertension in the study eye
- successful, uncomplicated cataract surgery using small incision phacoemulsification cataract surgery and insertion of a foldable posterior chamber IOL
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 the fellow 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.
About this study
Official title: Multicenter, Open-label, Single-arm Trial to Evaluate the Safety and Efficacy of iDose® TR (Travoprost Intraocular Implant) in Conjunction With Cataract Surgery
Subjects with cataract requiring extraction and who have open-angle glaucoma or ocular hypertension will undergo screening and washout from IOP-lowering medication, if applicable. Eligible subjects who meet all inclusion criteria and none of the exclusion criteria and who undergo successful cataract extraction with implantation of a posterior chamber intraocular lens (PC-IOL) will receive a travoprost intraocular implant and followed up for 12 months.
- Conditions
- Open Angle Glaucoma, Ocular Hypertension
- Being tested
- iDose TR
- 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 TRDrug
Also called travoprost intraocular implant
anchored intracameral implant containing travoprost
| Study group | Role | What they receive |
|---|---|---|
| iDose TR | Experimental | Travoprost Intraocular Implant administered intracamerally in the study eye at the Day 1 Visit following successful cataract surgery Receives: Drug: iDose TR |
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 the 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 posted29 Sep 2023
- Study start11 Sep 2023
- Primary completion18 Mar 2024
- Study completion20 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Open Angle GlaucomaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
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
- NCT06061718
- Sponsor's protocol ID
- GLK-101-02
- Status last verified
- May 2024
- First submitted
- 25 Sep 2023
- Last updated
- 3 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Singh IP, Voskanyan LA, Barber KM, Burden JH, Connolly L, Katz LJ, Usner DW, Kothe AC, Navratil T. Safety and efficacy of travoprost intracameral implant administered in combination with cataract surgery. Ther Adv Ophthalmol. 2025 Feb 14;17:25158414241310275. doi: 10.1177/25158414241310275. eCollection 2025 Jan-Dec.
PubMed 39959854
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Open-label, Single-arm Trial to Evaluate the Safety and Efficacy of iDose® TR (Travoprost Intraocular Implant) in Conjunction With Cataract Surgery
- ClinicalTrials.gov ID
- NCT06061718
- Acronym / sponsor ID
- GLK-101-02
- Conditions
- Open Angle Glaucoma, Ocular Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Glaukos CorporationIndustry (pharma, biotech, devices)
- Study start
- 11 Sep 2023 (actual)
- Primary completion
- 18 Mar 2024 (actual)
- Study completion
- 20 Dec 2024 (estimated)
- First posted
- 29 Sep 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.
Subjects with cataract requiring extraction and who have open-angle glaucoma or ocular hypertension will undergo screening and washout from IOP-lowering medication, if applicable. Eligible subjects who meet all inclusion criteria and none of the exclusion criteria and who undergo successful cataract extraction with implantation of a posterior chamber intraocular lens (PC-IOL) will receive a travoprost intraocular implant and followed up for 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| iDose TR | Experimental | Drug: iDose TRTravoprost Intraocular Implant administered intracamerally in the study eye at the Day 1 Visit following successful cataract surgery |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- clinically significant age-related cataract eligible for phacoemulsification in the study eye
- open-angle glaucoma or ocular hypertension in the study eye
- successful, uncomplicated cataract surgery using small incision phacoemulsification cataract surgery and insertion of a foldable posterior chamber IOL
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 the fellow 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 |
|---|---|---|
| iDose TRAlso: travoprost intraocular implantanchored intracameral implant containing travoprost | Drug | iDose TR |
Primary outcome
Change from baseline in mean diurnal IOP
Time frame: 3 months
Mean diurnal IOP at the Month 3 Visit minus the mean diurnal IOP at the Baseline Visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2024.
- Derived from this study: PubMed 39959854Singh IP, Voskanyan LA, Barber KM, Burden JH, Connolly L, Katz LJ, Usner DW, Kothe AC, Navratil T. Safety and efficacy of travoprost intracameral implant administered in combination with cataract surgery. Ther Adv Ophthalmol. 2025 Feb 14;17:25158414241310275. doi: 10.1177/25158414241310275. eCollection 2025 Jan-Dec.
- 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. This study is not recruiting at the moment.
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 3 study testing iDose TR in people with Open Angle Glaucoma and Ocular Hypertension, run by Glaukos Corporation at 1 site in Armenia.
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 3 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: status not confirmed, as of the sponsor's last update on 3 Jun 2024. 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 Armenia. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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?
On the ClinicalTrials.gov record for NCT06061718, which also lists 1 linked publication.
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 3 Jun 2024.