Open Angle GlaucomaPhase 2NCT04615403
Study of Exchange of Travoprost Intraocular Implant
A Phase 2 study testing Travoprost in people with Open Angle Glaucoma, run by Glaukos Corporation at 14 sites in 2 countries.
Trial summary
The study objective is to evaluate the safety of the operative and surgical exchange procedure of Travoprost Intraocular Implant in subjects with open-angle glaucoma or ocular hypertension. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open Angle Glaucoma
- What is being tested?
- Travoprost
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 14 sitesin 2 countries
- Study dates
- 19 Nov 2020to 28 Feb 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Able and willing to attend scheduled follow-up exams for the duration of the study
- Able and willing to provide written informed consent on the IRB (institutional review board)/IEC (institutional ethics committee)-approved Informed Consent form
- Best spectacle corrected visual acuity of 20/80 or better in each eye.
- Previously qualified for GC-009 clinical trial using the Travoprost Intraocular Implant with the travoprost intraocular implant (G2TR) that is present in the study eye.
Who cannot join
- Glaucoma status as follows:
- Traumatic, uveitic, neovascular, or angle-closure glaucoma; or glaucoma associated with vascular disorders
- Corneal status as follows:
- Any active inflammation or edema
- Any pathology for which, in the investigator's judgement, the following would be either at risk or contraindicated:
- Implantation of Travoprost Intraocular Implant
Show all 11Show fewer
- Compliance to elements of the study protocol (e.g., ophthalmic examinations, follow-up visits)
- Fellow eye status as follows:
- Fellow eye actively enrolled in this trial or any other clinical trial
- Subject status as follows:
- Pregnant or planning to become pregnant during the course of the study
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
United States13 sites
Texan Eye
Austin, Texas, 78746
Eye Center of northern Colorado, PC
Fort Collins, Colorado, 80525
Inland Eye Specialists
Hemet, California, 92545
D'Ambrosio Eye Care
Lancaster, Massachusetts, 01523
The Eye Associates of Manatee
Manatee, Florida, 34209
Lehmann Eye Center
Nacogdoches, Texas, 75965
Ocala Eye
Ocala, Florida, 34471
Oklahoma Eye Surgeons
Oklahoma City, Oklahoma, 73112
North Bath Eye Associates, Inc.
Petaluma, California, 94954
Center for Sight
Sarasota, Florida, 34239
Jones Eye Clinic
Sioux City, Iowa, 51104
Vance Thompson Vision
Sioux Falls, South Dakota, 57108
Northern New Jersey Eye Institute
South Orange, New Jersey, 07079
About this study
Official title: Prospective, Non-Randomized, Open-Label, Multi-Center, Single Arm Study of Exchange of Travoprost Intraocular Implant
The study objective is to evaluate the safety of the operative and surgical exchange procedure of Travoprost Intraocular Implant in subjects with open-angle glaucoma or ocular hypertension.
Read the detailed description
This prospective, non-randomized, open-label, multi-center, single arm, clinical trial intends to implant approximately 45 male and female subjects over 18 years old who have been diagnosed with open-angle glaucoma (OAG) or ocular hypertension (OHT). All subjects are required to meet eligibility criteria at Visit 1 (Screening). The purpose of this study is to evaluate the safety of the implantation and exchange of a Travoprost Intraocular Implant in subjects with open-angle glaucoma or ocular hypertension. Postoperatively, there are 6 follow-up visits over a 12 month period.
- Conditions
- Open Angle Glaucoma
- Being tested
- Travoprost
- 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.
TravoprostDrug
Implantation and exchange of a Travoprost Intraocular Implant through a clear corneal incision
| Study group | Role | What they receive |
|---|---|---|
| Implantation and Exchange | Experimental | Subjects will undergo implantation and exchange of a Travoprost Intraocular Implant through a small temporal clear corneal incision. Receives: Drug: Travoprost |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular Safety
Number of subjects with Adverse Events including intra-operative and post-operative events (TEAE's) in the study eye
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start19 Nov 2020
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glaukos Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04615403
- Sponsor's protocol ID
- IDOS-106-EXCH
- Status last verified
- Sep 2023
- First submitted
- 29 Oct 2020
- Last updated
- 26 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Berdahl JP, Lehmann RP, Jones JJ, Sarkisian SR Jr, Applegate D, Katz LJ, Kothe AC, Navratil T. Safety and Feasibility of the Exchange Procedure for the Travoprost Intracameral Implant for Open-Angle Glaucoma or Ocular Hypertension. Ophthalmol Ther. 2026 Apr;15(4):1485-1498. doi: 10.1007/s40123-026-01355-8. Epub 2026 Mar 14.
PubMed 41832303
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Non-Randomized, Open-Label, Multi-Center, Single Arm Study of Exchange of Travoprost Intraocular Implant
- ClinicalTrials.gov ID
- NCT04615403
- Acronym / sponsor ID
- IDOS-106-EXCH
- Conditions
- Open Angle Glaucoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Glaukos CorporationIndustry (pharma, biotech, devices)
- Study start
- 19 Nov 2020 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 4 Nov 2020 (actual)
- Results
- Posted 26 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study objective is to evaluate the safety of the operative and surgical exchange procedure of Travoprost Intraocular Implant in subjects with open-angle glaucoma or ocular hypertension.
Detailed description
This prospective, non-randomized, open-label, multi-center, single arm, clinical trial intends to implant approximately 45 male and female subjects over 18 years old who have been diagnosed with open-angle glaucoma (OAG) or ocular hypertension (OHT). All subjects are required to meet eligibility criteria at Visit 1 (Screening). The purpose of this study is to evaluate the safety of the implantation and exchange of a Travoprost Intraocular Implant in subjects with open-angle glaucoma or ocular hypertension. Postoperatively, there are 6 follow-up visits over a 12 month period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implantation and Exchange | Experimental | Drug: TravoprostSubjects will undergo implantation and exchange of a Travoprost Intraocular Implant through a small temporal clear corneal incision. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Able and willing to attend scheduled follow-up exams for the duration of the study
- Able and willing to provide written informed consent on the IRB (institutional review board)/IEC (institutional ethics committee)-approved Informed Consent form
- Best spectacle corrected visual acuity of 20/80 or better in each eye.
- Previously qualified for GC-009 clinical trial using the Travoprost Intraocular Implant with the travoprost intraocular implant (G2TR) that is present in the study eye.
Key exclusion criteria (11 listed)
- Glaucoma status as follows:
- Corneal status as follows:
- Any pathology for which, in the investigator's judgement, the following would be either at risk or contraindicated:
- Implantation of Travoprost Intraocular Implant
- Compliance to elements of the study protocol (e.g., ophthalmic examinations, follow-up visits)
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 |
|---|---|---|
| TravoprostImplantation and exchange of a Travoprost Intraocular Implant through a clear corneal incision | Drug | Implantation and Exchange |
Primary outcome
Ocular Safety
Time frame: 12 Months
Number of subjects with Adverse Events including intra-operative and post-operative events (TEAE's) in the study eye
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41832303Berdahl JP, Lehmann RP, Jones JJ, Sarkisian SR Jr, Applegate D, Katz LJ, Kothe AC, Navratil T. Safety and Feasibility of the Exchange Procedure for the Travoprost Intracameral Implant for Open-Angle Glaucoma or Ocular Hypertension. Ophthalmol Ther. 2026 Apr;15(4):1485-1498. doi: 10.1007/s40123-026-01355-8. Epub 2026 Mar 14.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Travoprost in people with Open Angle Glaucoma, run by Glaukos Corporation at 14 sites in 2 countries.
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 4 inclusion and 11 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: finished, as of the sponsor's last update on 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Philippines. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Ocular Safety (time frame: 12 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 NCT04615403, 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 26 Sep 2023; AzTrials last refreshed its copy on 8 Nov 2026.