Glaucoma, Open-AnglePhase 2NCT06582732

Performance of the Travoprost Intraocular Implant

A Phase 2 study testing Travoprost Intracameral Implant exchanged at Month 12, Travoprost Intracameral Implant exchanged at Month 3 and Travoprost Intracameral Implant exchanged at Month 6 in people with Glaucoma, Open-Angle and Ocular Hypertension, run by Glaukos Corporation at 1 site in Armenia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

To evaluate the performance of the Travoprost Intracameral Implant by determining residual drug in explanted implants of the Travoprost Intracameral Implant and by determining aqueous humor concentrations of travoprost free acid at specified timepoints post administration through 24 months Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Glaucoma, Open-Angle, Ocular Hypertension
What is being tested?: Travoprost Intracameral Implant exchanged at Month 12, Travoprost Intracameral Implant exchanged at Month 3 and Travoprost Intracameral Implant exchanged at Month 6
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 210 participants
Where: 1 siteArmenia
Study dates: 10 Mar 2021to 2 Nov 2023
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

Diagnosis of either open angle glaucoma (i.e. primary, pseudoexfoliation, or pigmentary glaucoma) or ocular hypertenson
Zero to three topical intraocular pressure lowering medications at the time of Visit 1 (Screening) exam.
Best spectacle corrected visual acuity of 16 letters or more correctly read at 4 meters or better in each eye.
Open angle as defined by Shaffer grade ≥ 3 at slit-lamp at the planned implantation site

Who cannot join

Traumatic, uveitic, neovascular, or angle-closure glaucoma; or glaucoma associated with vascular disorders
Active ocular inflammation, infection or edema
Clinically significant dystrophy (e.g., bullous keratopathy, Fuch's dystrophy) or clinically significant guttata

Trial locations and contacts

1 site in 1 country.

Armenia1 site

Glaukos Clinical Study Site
Yerevan

Other trials in Armenia

About this study

Official title: Prospective, Non-Randomized, Open-Label, Single Center Study to Evaluate the Performance of the Travoprost Intraocular Implant

Conditions: Glaucoma, Open-Angle, Ocular Hypertension
Being tested: Travoprost Intracameral Implant exchanged at Month 12, Travoprost Intracameral Implant exchanged at Month 3, Travoprost Intracameral Implant exchanged at Month 6, Travoprost Intracameral Implant exchanged at Month 24, Travoprost intracameral implant exchanged at Month 21
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.

Travoprost Intracameral Implant exchanged at Month 12Drug
Also called iDose TR
intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 12
Travoprost Intracameral Implant exchanged at Month 3Drug
Also called iDose TR
intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 3
Travoprost Intracameral Implant exchanged at Month 6Drug
Also called iDose TR
intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 6
Travoprost Intracameral Implant exchanged at Month 24Drug
Also called iDose TR
intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 24
Travoprost intracameral implant exchanged at Month 21Drug
Also called iDose TR
intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 21
Travoprost intracameral implant exchanged at Month 18Drug
Also called iDose TR
intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 18
Travoprost intracameral implant exchanged at Month 15Drug
Also called iDose TR
intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 15

Study groups in NCT06582732
Study group	Role	What they receive
Cohort 1 (12-month exchange)	Experimental	Travoprost Intracameral Implant Exchanged at Month 12 Receives: Drug: Travoprost Intracameral Implant exchanged at Month 12
Cohort 2 (3-month exchange)	Experimental	Travoprost Intracameral Implant Exchanged at Month 3 Receives: Drug: Travoprost Intracameral Implant exchanged at Month 3
Cohort 3 (6-month exchange)	Experimental	Travoprost Intracameral Implant Exchanged at Month 6 Receives: Drug: Travoprost Intracameral Implant exchanged at Month 6
Cohort 4 (24-month exchange)	Experimental	Travoprost Intracameral Implant Exchanged at Month 24 Receives: Drug: Travoprost Intracameral Implant exchanged at Month 24
Cohort 5 (21-month exchange)	Experimental	Travoprost Intracameral Implant Exchanged at Month 21 Receives: Drug: Travoprost intracameral implant exchanged at Month 21
Cohort 6 (18-month exchange)	Experimental	Travoprost Intracameral Implant Exchanged at Month 18 Receives: Drug: Travoprost intracameral implant exchanged at Month 18
Cohort 7 (15-month exchange)	Experimental	Travoprost Intracameral Implant Exchanged at Month 15 Receives: Drug: Travoprost intracameral implant exchanged at Month 15

What is being measured

The primary outcome is the main question the study is designed to answer.

Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 12 Months Post-administration
concentration of travoprost free acid (ng/mL) in the aqueous humor 12 months post-administration as assessed by liquid chromatography tandem mass spectrometry (LC-MS/MS)
Measured: month 12
Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 3 Months Post-administration
concentration of travoprost free acid (ng/mL) in the aqueous humor 3 months post-administration as assessed by LC-MS/MS
Measured: month 3
Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 6 Months Post-administration
concentration of travoprost free acid (ng/mL) in the aqueous humor 6 months post-administration as assessed by LC-MS/MS
Measured: month 6
Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 24 Months Post-administration
concentration of travoprost free acid (ng/mL) in the aqueous humor 24 months post-administration as assessed by LC-MS/MS
Measured: month 24
Travoprost Free Acid Concentration(ng/mL) in Aqueous Humor 21 Months Post-administration
concentration of travoprost free acid (ng/mL) in the aqueous humor 21 months post-administration as assessed by LC-MS/MS
Measured: month 21
Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 18 Months Post-administration
concentration of travoprost free acid (ng/mL) in the aqueous humor 18 months post-administration as assessed by LC-MS/MS
Measured: month 18
Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 15 Months Post-administration
concentration of travoprost free acid (ng/mL) in the aqueous humor 15 months post-administration as assessed by LC-MS/MS
Measured: month 15

Secondary outcomes (7)

Percent Residual Travoprost in Explanted Implant 12 Months Post-administration
percent of travoprost compared to baseline in explanted implant 12 months post-administration as assessed by high performance liquid chromatography (HPLC)
Measured: month 12
Percent Residual Travoprost in Explanted Implant 3 Months Post-administration
percent of travoprost compared to baseline in explanted implant 3 months post-administration as assessed by HPLC
Measured: month 3
Percent Residual Travoprost in Explanted Implant 6 Months Post-administration
percent of travoprost compared to baseline in explanted implant 6 months post-administration as assessed by HPLC
Measured: month 6
Percent Residual Travoprost in Explanted Implant 24 Months Post-administration
percent of travoprost compared to baseline in explanted implant 24 months post-administration as assessed by HPLC
Measured: month 24
Percent Residual Travoprost in Explanted Implant 21 Months Post-administration
percent of travoprost compared to baseline in explanted implant 21 months post-administration as assessed by HPLC
Measured: month 21
Percent Residual Travoprost in Explanted Implant 18 Months Post-administration
percent of travoprost compared to baseline in explanted implant 18 months post-administration as assessed by HPLC
Measured: month 18
Percent Residual Travoprost in Explanted Implant 15 Months Post-administration
percent of travoprost compared to baseline in explanted implant 15 months post-administration as assessed by HPLC
Measured: month 15

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Mar 20212 Nov 2023

First posted3 Sep 2024
Study start10 Mar 2021
Primary completion2 Nov 2023
Study completion2 Nov 2023

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 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 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 210 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06582732
Sponsor's protocol ID: IDOS-402-IVIV
Status last verified: Sep 2024
First submitted: 30 Aug 2024
Last updated: 15 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Szekely G, Voskanyan LA, Stephens KG, Doan LV, Seal JR, ElMallah MK, Fjield T, Applegate D, Usner DW, Katz LJ, Kothe AC, Navratil T. Aqueous Humor Concentrations of Travoprost Free Acid and Residual Drug in Explanted Implants from Patients Administered a Travoprost Intracameral Implant. Ophthalmol Ther. 2025 May;14(5):989-1003. doi: 10.1007/s40123-025-01130-1. Epub 2025 Mar 24.
PubMed 40126812

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
Open Angle Glaucoma (OAG), Glaucoma
Active, not recruitingObservational study
Impact of Glaucoma and Visual Field Loss on Life Space
Primary Open-angle Glaucoma

All Glaucoma, Open-Angle trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective, Non-Randomized, Open-Label, Single Center Study to Evaluate the Performance of the Travoprost Intraocular Implant
ClinicalTrials.gov ID: NCT06582732
Acronym / sponsor ID: IDOS-402-IVIV
Conditions: Glaucoma, Open-Angle, Ocular Hypertension
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 210 participants (actual)
Lead sponsor: Glaukos CorporationIndustry (pharma, biotech, devices)
Study start: 10 Mar 2021 (actual)
Primary completion: 2 Nov 2023 (actual)
Study completion: 2 Nov 2023 (actual)
First posted: 3 Sep 2024 (actual)
Results: Posted 15 Oct 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 7

Arm	Type	Receives
Cohort 1 (12-month exchange)	Experimental	Drug: Travoprost Intracameral Implant exchanged at Month 12Travoprost Intracameral Implant Exchanged at Month 12
Cohort 2 (3-month exchange)	Experimental	Drug: Travoprost Intracameral Implant exchanged at Month 3Travoprost Intracameral Implant Exchanged at Month 3
Cohort 3 (6-month exchange)	Experimental	Drug: Travoprost Intracameral Implant exchanged at Month 6Travoprost Intracameral Implant Exchanged at Month 6
Cohort 4 (24-month exchange)	Experimental	Drug: Travoprost Intracameral Implant exchanged at Month 24Travoprost Intracameral Implant Exchanged at Month 24
Cohort 5 (21-month exchange)	Experimental	Drug: Travoprost intracameral implant exchanged at Month 21Travoprost Intracameral Implant Exchanged at Month 21
Cohort 6 (18-month exchange)	Experimental	Drug: Travoprost intracameral implant exchanged at Month 18Travoprost Intracameral Implant Exchanged at Month 18
Cohort 7 (15-month exchange)	Experimental	Drug: Travoprost intracameral implant exchanged at Month 15Travoprost Intracameral Implant Exchanged at Month 15

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Diagnosis of either open angle glaucoma (i.e. primary, pseudoexfoliation, or pigmentary glaucoma) or ocular hypertenson
Zero to three topical intraocular pressure lowering medications at the time of Visit 1 (Screening) exam.
Best spectacle corrected visual acuity of 16 letters or more correctly read at 4 meters or better in each eye.
Open angle as defined by Shaffer grade ≥ 3 at slit-lamp at the planned implantation site

Key exclusion criteria (3 listed)

Traumatic, uveitic, neovascular, or angle-closure glaucoma; or glaucoma associated with vascular disorders
Active ocular inflammation, infection or edema
Clinically significant dystrophy (e.g., bullous keratopathy, Fuch's dystrophy) or clinically significant guttata

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 Intracameral Implant exchanged at Month 12Also: iDose TRintracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 12	Drug	Cohort 1 (12-month exchange)
Travoprost Intracameral Implant exchanged at Month 3Also: iDose TRintracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 3	Drug	Cohort 2 (3-month exchange)
Travoprost Intracameral Implant exchanged at Month 6Also: iDose TRintracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 6	Drug	Cohort 3 (6-month exchange)
Travoprost Intracameral Implant exchanged at Month 24Also: iDose TRintracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 24	Drug	Cohort 4 (24-month exchange)
Travoprost intracameral implant exchanged at Month 21Also: iDose TRintracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 21	Drug	Cohort 5 (21-month exchange)
Travoprost intracameral implant exchanged at Month 18Also: iDose TRintracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 18	Drug	Cohort 6 (18-month exchange)
Travoprost intracameral implant exchanged at Month 15Also: iDose TRintracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 15	Drug	Cohort 7 (15-month exchange)

Primary outcome

Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 12 Months Post-administration
Time frame: month 12
concentration of travoprost free acid (ng/mL) in the aqueous humor 12 months post-administration as assessed by liquid chromatography tandem mass spectrometry (LC-MS/MS)
Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 3 Months Post-administration
Time frame: month 3
concentration of travoprost free acid (ng/mL) in the aqueous humor 3 months post-administration as assessed by LC-MS/MS
Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 6 Months Post-administration
Time frame: month 6
concentration of travoprost free acid (ng/mL) in the aqueous humor 6 months post-administration as assessed by LC-MS/MS
Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 24 Months Post-administration
Time frame: month 24
concentration of travoprost free acid (ng/mL) in the aqueous humor 24 months post-administration as assessed by LC-MS/MS
Travoprost Free Acid Concentration(ng/mL) in Aqueous Humor 21 Months Post-administration
Time frame: month 21
concentration of travoprost free acid (ng/mL) in the aqueous humor 21 months post-administration as assessed by LC-MS/MS
Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 18 Months Post-administration
Time frame: month 18
concentration of travoprost free acid (ng/mL) in the aqueous humor 18 months post-administration as assessed by LC-MS/MS
Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 15 Months Post-administration
Time frame: month 15
concentration of travoprost free acid (ng/mL) in the aqueous humor 15 months post-administration as assessed by LC-MS/MS

7 secondary outcomes

Percent Residual Travoprost in Explanted Implant 12 Months Post-administration
Time frame: month 12
Percent Residual Travoprost in Explanted Implant 3 Months Post-administration
Time frame: month 3
Percent Residual Travoprost in Explanted Implant 6 Months Post-administration
Time frame: month 6
Percent Residual Travoprost in Explanted Implant 24 Months Post-administration
Time frame: month 24
Percent Residual Travoprost in Explanted Implant 21 Months Post-administration
Time frame: month 21
Percent Residual Travoprost in Explanted Implant 18 Months Post-administration
Time frame: month 18
Percent Residual Travoprost in Explanted Implant 15 Months Post-administration
Time frame: month 15

Results and safety

Results posted to the registry on 15 Oct 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1 (12-month Exchange)	30	29
Cohort 2 (3-month Exchange)	30	29
Cohort 3 (6-month Exchange)	30	28
Cohort 4 (24-month Exchange)	30	27
Cohort 5 (21-month Exchange)	30	25
Cohort 6 (18-month Exchange)	30	29
Cohort 7 (15-month Exchange)	30	28

Primary outcome: Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 12 Months Post-administration

Time frame: month 12. Mean (Standard Deviation). Unit: ng/mL

Measure	Cohort 1 (12-month Exchange) n = 29
Value	5.57 (3.02)

Population analysed: study eyes

Primary outcome: Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 3 Months Post-administration

Time frame: month 3. Mean (Standard Deviation). Unit: ng/mL

Measure	Cohort 2 (3-month Exchange) n = 27
Value	4.98 (2.50)

Population analysed: study eyes

Primary outcome: Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 6 Months Post-administration

Time frame: month 6. Mean (Standard Deviation). Unit: ng/mL

Measure	Cohort 3 (6-month Exchange) n = 25
Value	3.74 (2.22)

Population analysed: study eyes

Primary outcome: Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 24 Months Post-administration

Time frame: month 24. Mean (Standard Deviation). Unit: ng/mL

Measure	Cohort 4 (24-month Exchange) n = 25
Value	3.35 (1.51)

Population analysed: study eyes

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: initial travoprost intracameral implant period plus 4 weeks post-exchange. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1 (12-month Exchange)	1 of 30 (3.3%)	4 of 30 (13.3%)	1 of 30
Cohort 2 (3-month Exchange)	0 of 30 (0%)	0 of 30 (0%)	0 of 30
Cohort 3 (6-month Exchange)	0 of 30 (0%)	5 of 30 (16.7%)	0 of 30
Cohort 4 (24-month Exchange)	0 of 30 (0%)	3 of 30 (10%)	0 of 30
Cohort 5 (21-month Exchange)	1 of 30 (3.3%)	0 of 30 (0%)	1 of 30
Cohort 6 (18-month Exchange)	0 of 30 (0%)	1 of 30 (3.3%)	0 of 30
Cohort 7 (15-month Exchange)	0 of 30 (0%)	1 of 30 (3.3%)	0 of 30

Limitations and caveats (from the sponsor): Study was open-label, non-randomized and conducted at a single site; however, the endpoints were objective and analyses of aqueous humor concentrations of travoprost free acid and of residual travoprost in explants were performed by a third party

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40126812Szekely G, Voskanyan LA, Stephens KG, Doan LV, Seal JR, ElMallah MK, Fjield T, Applegate D, Usner DW, Katz LJ, Kothe AC, Navratil T. Aqueous Humor Concentrations of Travoprost Free Acid and Residual Drug in Explanted Implants from Patients Administered a Travoprost Intracameral Implant. Ophthalmol Ther. 2025 May;14(5):989-1003. doi: 10.1007/s40123-025-01130-1. Epub 2025 Mar 24.
Individual participant dataSharing planned: No

Related trials for Glaucoma, Open-Angle

RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
Open Angle Glaucoma (OAG), Glaucoma
Active, not recruitingObservational study
Impact of Glaucoma and Visual Field Loss on Life Space
Primary Open-angle Glaucoma

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.

Kerry Stephens 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?

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 3 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 15 Oct 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 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 15 Oct 2024). 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?

Travoprost Free Acid Concentration (ng/mL) in Aqueous Humor 12 Months Post-administration (time frame: month 12). The study lists 7 primary outcomes in all. 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 NCT06582732, 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 15 Oct 2024.