Glaucoma, Open-AnglePhase 3NCT03519386

Randomized Study Comparing Two Models of a Travoprost Intraocular Implant to Timolol Maleate Ophthalmic Solution, 0.5%

A Phase 3 study testing G2-TR intraocular implant containing travoprost in people with Glaucoma, Open-Angle and Ocular Hypertension, run by Glaukos Corporation at 1 site in United States.

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

Phase III study to compare the safety and efficacy of intraocular implants containing travoprost at two different elution rates versus Timolol Maleate Ophthalmic Solution, 0.5% (timolol) in reducing elevated intraocular pressure in subjects with open-angle glaucoma (OAG) or ocular hypertension (OHT). 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?: G2-TR intraocular implant containing travoprost
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 590 participants
Where: 1 siteUnited States
Study dates: 26 Jul 2018to 2 Apr 2024
Phase: Phase 3
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

Diagnosed with open-angle glaucoma or ocular hypertension.
C/D ratio ≤ 0.8
Zero to three preoperative ocular hypotensive medications

Who cannot join

Active corneal inflammation or edema.
Retinal disorders not associated with glaucoma.

Trial locations and contacts

1 site in 1 country.

United States1 site

Vance Thompson Vision
Sioux Falls, South Dakota, 57108

Other trials in United States

About this study

Official title: Prospective, Randomized Phase III Study Comparing Two Models of a Travoprost Intraocular Implant to Timolol Maleate Ophthalmic Solution, 0.5%

Read the detailed description

This is a prospective, randomized, double-masked, active-controlled, parallel-group, multi-center trial comparing the efficacy and safety of the Model G2TR 063 Travoprost Intraocular Implant and the Model G2TR-125 Travoprost Intraocular Implant to topical timolol in subjects with OAG or OHT. The staff who record key efficacy measures and the study subjects will remain masked to study treatment.

Conditions: Glaucoma, Open-Angle, Ocular Hypertension
Being tested: G2-TR intraocular implant containing travoprost, Sham surgery + active-comparator eye drops
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.

G2-TR intraocular implant containing travoprostCombination product
Also called Implant Group
Provided in Arm/Group descriptions.
Sham surgery + active-comparator eye dropsDrug
Also called Control Group
Sham surgery plus postoperative active-comparator eye drops (timolol maleate ophthalmic solution, 0.5%).

Study groups in NCT03519386
Study group	Role	What they receive
Implant Group 1	Experimental	G2-TR intraocular implant containing travoprost 75 mcg with high elution rate, plus postoperative placebo eye drops. Receives: Combination Product: G2-TR intraocular implant containing travoprost
Implant Group 2	Experimental	G2-TR intraocular implant containing travoprost 75 mcg with low elution rate, plus postoperative placebo eye drops. Receives: Combination Product: G2-TR intraocular implant containing travoprost
Control Group	Active comparator	Sham surgery + active-comparator eye drops Receives: Drug: Sham surgery + active-comparator eye drops

What is being measured

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

Change From Baseline in Diurnal IOP (as Measured at 8AM and 10AM) Through 3 Months Postoperative
Change from time-matched baseline in IOP at 8AM and 10AM at Day 10, Week 6 and Month 3.
Day 10 8AM IOP minus Baseline 8AM IOP; Day 10 10AM IOP minus Baseline 10AM IOP; Week 6 8AM IOP minus Baseline 8AM IOP; Week 6 10AM IOP minus Baseline 10AM IOP; Month 3 8AM IOP minus Baseline 8AM IOP; Month 3 10AM IOP minus Baseline 10AM IOP.
Measured: 3 months

Secondary outcomes (1)

Mean IOP (Control Group vs. Each Implant Group) Through 12 Months Postoperative
Difference in mean IOP, between each test group and the control group, for IOP measurements through the Month 12 follow-up visit
Measured: 12 months

Timeline

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

26 Jul 20182 Apr 2024

First posted9 May 2018
Study start26 Jul 2018
Primary completion5 Apr 2022
Study completion2 Apr 2024

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 (4)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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 590 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03519386
Sponsor's protocol ID: GC-010
Status last verified: Nov 2024
First submitted: 26 Apr 2018
Last updated: 29 Nov 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Singh IP, Berdahl JP, Sarkisian SR Jr, Voskanyan LA, Ang RE, Doan LV, Applegate D, Shen Y, Katz LJ, Kothe AC, Navratil T. Long-Term Safety and Efficacy Evaluation of Travoprost Intracameral Implant Based on Pooled Analyses from Two Phase III Trials. Drugs. 2024 Oct;84(10):1299-1311. doi: 10.1007/s40265-024-02074-9. Epub 2024 Sep 6.
PubMed 39240530
Bacharach J, Doan LV, Stephens KG, Usner DW, Kothe AC, Katz LJ, Navratil T. Travoprost Intracameral Implant Demonstrates Superior IOP Lowering Versus Topical Prostaglandin Analog Monotherapy in Patients with Open-Angle Glaucoma or Ocular Hypertension. Ophthalmol Ther. 2024 Sep;13(9):2357-2367. doi: 10.1007/s40123-024-00992-1. Epub 2024 Jul 10.
PubMed 38985408
Sarkisian SR, Ang RE, Lee AM, Berdahl JP, Heersink SB, Burden JH, Doan LV, Stephens KG, Applegate D, Kothe AC, Usner DW, Katz LJ, Navratil T. Travoprost Intracameral Implant for Open-Angle Glaucoma or Ocular Hypertension: 12-Month Results of a Randomized, Double-Masked Trial. Ophthalmol Ther. 2024 Apr;13(4):995-1014. doi: 10.1007/s40123-024-00898-y. Epub 2024 Feb 12.
PubMed 38345710
Belamkar A, Harris A, Zukerman R, Siesky B, Oddone F, Verticchio Vercellin A, Ciulla TA. Sustained release glaucoma therapies: Novel modalities for overcoming key treatment barriers associated with topical medications. Ann Med. 2022 Dec;54(1):343-358. doi: 10.1080/07853890.2021.1955146.
PubMed 35076329

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

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All Glaucoma, Open-Angle trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective, Randomized Phase III Study Comparing Two Models of a Travoprost Intraocular Implant to Timolol Maleate Ophthalmic Solution, 0.5%
ClinicalTrials.gov ID: NCT03519386
Acronym / sponsor ID: GC-010
Conditions: Glaucoma, Open-Angle, Ocular Hypertension
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 590 participants (actual)
Lead sponsor: Glaukos CorporationIndustry (pharma, biotech, devices)
Study start: 26 Jul 2018 (actual)
Primary completion: 5 Apr 2022 (actual)
Study completion: 2 Apr 2024 (actual)
First posted: 9 May 2018 (actual)
Results: Posted 14 Sep 2023

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Implant Group 1	Experimental	Combination Product: G2-TR intraocular implant containing travoprostG2-TR intraocular implant containing travoprost 75 mcg with high elution rate, plus postoperative placebo eye drops.
Implant Group 2	Experimental	Combination Product: G2-TR intraocular implant containing travoprostG2-TR intraocular implant containing travoprost 75 mcg with low elution rate, plus postoperative placebo eye drops.
Control Group	Active comparator	Drug: Sham surgery + active-comparator eye dropsSham surgery + active-comparator eye drops

Who may qualify

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

Key inclusion criteria (3 listed)

Diagnosed with open-angle glaucoma or ocular hypertension.
C/D ratio ≤ 0.8
Zero to three preoperative ocular hypotensive medications

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
G2-TR intraocular implant containing travoprostAlso: Implant GroupProvided in Arm/Group descriptions.	Combination product	Implant Group 1, Implant Group 2
Sham surgery + active-comparator eye dropsAlso: Control GroupSham surgery plus postoperative active-comparator eye drops (timolol maleate ophthalmic solution, 0.5%).	Drug	Control Group

Primary outcome

Change From Baseline in Diurnal IOP (as Measured at 8AM and 10AM) Through 3 Months Postoperative
Time frame: 3 months
Change from time-matched baseline in IOP at 8AM and 10AM at Day 10, Week 6 and Month 3. Day 10 8AM IOP minus Baseline 8AM IOP; Day 10 10AM IOP minus Baseline 10AM IOP; Week 6 8AM IOP minus Baseline 8AM IOP; Week 6 10AM IOP minus Baseline 10AM IOP; Month 3 8AM IOP minus Baseline 8AM IOP; Month 3 10AM IOP minus Baseline 10AM IOP.

1 secondary outcome

Mean IOP (Control Group vs. Each Implant Group) Through 12 Months Postoperative
Time frame: 12 months

Results and safety

Results posted to the registry on 14 Sep 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Implant Group 1	200	0
Implant Group 2	197	0
Control Group	193	0

Primary outcome: Change From Baseline in Diurnal IOP (as Measured at 8AM and 10AM) Through 3 Months Postoperative

Time frame: 3 months. Least squares mean (Standard Error). Unit: mmHg

Measure	Implant Group 1 n = 200	Implant Group 2 n = 197	Control Group n = 193
Day 10, 8AM	-8.40 (0.24)	-8.48 (0.24)	-7.69 (0.24)
Day 10, 10AM	-8.35 (0.24)	-8.44 (0.24)	-7.20 (0.24)
Week 6, 8AM	-7.34 (0.24)	-7.26 (0.25)	-7.09 (0.25)
Week 6, 10AM	-7.59 (0.24)	-7.62 (0.24)	-6.85 (0.24)
Month 3, 8AM	-6.59 (0.26)	-6.59 (0.26)	-6.69 (0.27)
Month 3, 10AM	-6.56 (0.26)	-6.68 (0.26)	-6.52 (0.27)

Implant Group 2 vs Control Group: Mean Difference (Final Values): -0.79 (95% CI -1.45 to -0.13)
Implant Group 2 vs Control Group: Mean Difference (Final Values): -1.24 (95% CI -1.92 to -0.56)
Implant Group 2 vs Control Group: Mean Difference (Final Values): -0.18 (95% CI -0.86 to 0.51)

Population analysed: intent to treatment analysis set which includes all randomized subjects with analyses performed according to original treatment assignment, regardless of actual treatment received

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 12 months post-operative. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Implant Group 1	5 of 200 (2.5%)	16 of 200 (8%)	2 of 200
Implant Group 2	6 of 195 (3.1%)	21 of 195 (10.8%)	0 of 195
Control Group	7 of 194 (3.6%)	4 of 194 (2.1%)	4 of 194

Limitations and caveats (from the sponsor): This is an ongoing double-masked trial. Therefore, limited adverse event data are presented in order to prevent unmasking.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39240530Singh IP, Berdahl JP, Sarkisian SR Jr, Voskanyan LA, Ang RE, Doan LV, Applegate D, Shen Y, Katz LJ, Kothe AC, Navratil T. Long-Term Safety and Efficacy Evaluation of Travoprost Intracameral Implant Based on Pooled Analyses from Two Phase III Trials. Drugs. 2024 Oct;84(10):1299-1311. doi: 10.1007/s40265-024-02074-9. Epub 2024 Sep 6.
Derived from this study: PubMed 38985408Bacharach J, Doan LV, Stephens KG, Usner DW, Kothe AC, Katz LJ, Navratil T. Travoprost Intracameral Implant Demonstrates Superior IOP Lowering Versus Topical Prostaglandin Analog Monotherapy in Patients with Open-Angle Glaucoma or Ocular Hypertension. Ophthalmol Ther. 2024 Sep;13(9):2357-2367. doi: 10.1007/s40123-024-00992-1. Epub 2024 Jul 10.
Derived from this study: PubMed 38345710Sarkisian SR, Ang RE, Lee AM, Berdahl JP, Heersink SB, Burden JH, Doan LV, Stephens KG, Applegate D, Kothe AC, Usner DW, Katz LJ, Navratil T. Travoprost Intracameral Implant for Open-Angle Glaucoma or Ocular Hypertension: 12-Month Results of a Randomized, Double-Masked Trial. Ophthalmol Ther. 2024 Apr;13(4):995-1014. doi: 10.1007/s40123-024-00898-y. Epub 2024 Feb 12.
Derived from this study: PubMed 35076329Belamkar A, Harris A, Zukerman R, Siesky B, Oddone F, Verticchio Vercellin A, Ciulla TA. Sustained release glaucoma therapies: Novel modalities for overcoming key treatment barriers associated with topical medications. Ann Med. 2022 Dec;54(1):343-358. doi: 10.1080/07853890.2021.1955146.

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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.

Kerry Stephens, O.D. 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 3 study testing G2-TR intraocular implant containing travoprost in people with Glaucoma, Open-Angle and Ocular Hypertension, 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 3 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: finished, as of the sponsor's last update on 29 Nov 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 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 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?

Yes. Results are posted in the registry (first posted 14 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?

Change From Baseline in Diurnal IOP (as Measured at 8AM and 10AM) Through 3 Months Postoperative (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 NCT03519386, which also lists 4 linked publications.

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 29 Nov 2024.