Glaucoma Open-anglePhase 2NCT02754596

Study Comparing Travoprost Intraocular Implants to Timolol Ophthalmic Solution

A Phase 2 study testing Travoprost Intraocular Implant, high elution, Travoprost Intraocular Implant, low elution and Timolol Maleate Ophthalmic Solution, 0.5% in people with Glaucoma Open-angle, 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

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Trial summary

This is a randomized trial comparing two elution doses of the Travoprost Intraocular implant to timolol ophthalmic solution. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Glaucoma Open-angle
What is being tested?: Travoprost Intraocular Implant, high elution, Travoprost Intraocular Implant, low elution and Timolol Maleate Ophthalmic Solution, 0.5%
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 154 participants
Where: 1 siteUnited States
Study dates: 29 Mar 2016to 21 Jul 2020
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

Open angle glaucoma

Who cannot join

Uveitic, neovascular, or angle closure glaucoma; or glaucoma associated with vascular disorders.
Functionally significant visual field loss, including severe nerve fiber bundle defects.
Prior glaucoma surgery.
Uncontrolled systemic disease, pregnant females or those planning a pregnancy.
Other ocular status conditions, etc.

Trial locations and contacts

1 site in 1 country.

United States1 site

John Berdahl, MD
Sioux Falls, South Dakota, 57108

Other trials in United States

About this study

Official title: Prospective, Randomized Phase II Study Comparing Two Elution Rates of Glaukos Travoprost Intraocular Implants to Timolol Maleate Ophthalmic Solution, USP 0.5%

This is a randomized trial comparing two elution doses of the Travoprost Intraocular implant to timolol ophthalmic solution.

Read the detailed description

This is a randomized trial comparing two elution doses of the Travoprost Intraocular implant to timolol ophthalmic solution in patients with open-angle glaucoma. Study assessments will include IOP and medication use as well as safety parameters.

Conditions: Glaucoma Open-angle
Being tested: Travoprost Intraocular Implant, high elution, Travoprost Intraocular Implant, low elution, Timolol Maleate Ophthalmic Solution, 0.5%
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.

Travoprost Intraocular Implant, high elutionDrug
Surgical implant placed within the eye to elute travoprost.
Travoprost Intraocular Implant, low elutionDrug
Surgical implant placed within the eye to elute travoprost
Timolol Maleate Ophthalmic Solution, 0.5%Drug
Instillation of one drop of timolol in the study eye twice daily

Study groups in NCT02754596
Study group	Role	What they receive
Travoprost Intraocular Implant, high elution	Experimental	This implant will be surgically implanted and elute travoprost, a prostaglandin. Receives: Drug: Travoprost Intraocular Implant, high elution
Travoprost Intraocular Implant, low elution	Experimental	This implant will be surgically implanted and elute travoprost, a prostaglandin. Receives: Drug: Travoprost Intraocular Implant, low elution
Timolol Maleate Ophthalmic Solution, 0.5%	Active comparator	Timolol, a beta blocker, will be dosed twice daily Receives: Drug: Timolol Maleate Ophthalmic Solution, 0.5%

What is being measured

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

IOP (mmHg) Change From Baseline at Week 12
Change from baseline in IOP (measured in mmHg) at week 12. Negative values represent reductions in IOP from baseline.
Measured: 12 weeks

Timeline

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

29 Mar 201621 Jul 2020

First posted28 Apr 2016 (estimated)
Study start29 Mar 2016
Primary completion1 Aug 2017
Study completion21 Jul 2020

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.
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: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 154 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02754596
Sponsor's protocol ID: GC-009
Status last verified: Sep 2023
First submitted: 15 Mar 2016
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: The datasets generated during and/or analyzed during the current study are not publicly available at this time due to ongoing U.S. Food and Drug Administration review of a New Drug Application for the travoprost intraocular implant.

Publications

Berdahl JP, Sarkisian SR Jr, Ang RE, Doan LV, Kothe AC, Usner DW, Katz LJ, Navratil T; Travoprost Intraocular Implant Study Group. Efficacy and Safety of the Travoprost Intraocular Implant in Reducing Topical IOP-Lowering Medication Burden in Patients with Open-Angle Glaucoma or Ocular Hypertension. Drugs. 2024 Jan;84(1):83-97. doi: 10.1007/s40265-023-01973-7. Epub 2023 Dec 7.
PubMed 38060092

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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Evaluation the Safety and Effectiveness of the GORE GDI in Adult Subjects With Primary Open-angle Glaucoma in Whom Previous Medical and Surgical Treatment Have Failed.
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Electrical Stimulation for the Treatment of Optic Neuropathies
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The Effect of Lumify™ on Ocular Redness, Intraocular Pressure, and Eyelid Position in Glaucoma Patients
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All Glaucoma Open-angle trials

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, Randomized Phase II Study Comparing Two Elution Rates of Glaukos Travoprost Intraocular Implants to Timolol Maleate Ophthalmic Solution, USP 0.5%
ClinicalTrials.gov ID: NCT02754596
Acronym / sponsor ID: GC-009
Conditions: Glaucoma Open-angle
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 154 participants (actual)
Lead sponsor: Glaukos CorporationIndustry (pharma, biotech, devices)
Study start: 29 Mar 2016 (actual)
Primary completion: 1 Aug 2017 (actual)
Study completion: 21 Jul 2020 (actual)
First posted: 28 Apr 2016 (estimated)
Results: Posted 9 Aug 2023

Clinical summary

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

This is a randomized trial comparing two elution doses of the Travoprost Intraocular implant to timolol ophthalmic solution.

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
Travoprost Intraocular Implant, high elution	Experimental	Drug: Travoprost Intraocular Implant, high elutionThis implant will be surgically implanted and elute travoprost, a prostaglandin.
Travoprost Intraocular Implant, low elution	Experimental	Drug: Travoprost Intraocular Implant, low elutionThis implant will be surgically implanted and elute travoprost, a prostaglandin.
Timolol Maleate Ophthalmic Solution, 0.5%	Active comparator	Drug: Timolol Maleate Ophthalmic Solution, 0.5%Timolol, a beta blocker, will be dosed twice daily

Who may qualify

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

Key inclusion criteria (1 listed)

Open angle glaucoma

Key exclusion criteria (5 listed)

Uveitic, neovascular, or angle closure glaucoma; or glaucoma associated with vascular disorders.
Functionally significant visual field loss, including severe nerve fiber bundle defects.
Prior glaucoma surgery.
Uncontrolled systemic disease, pregnant females or those planning a pregnancy.
Other ocular status conditions, etc.

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 Intraocular Implant, high elutionSurgical implant placed within the eye to elute travoprost.	Drug	Travoprost Intraocular Implant, high elution
Travoprost Intraocular Implant, low elutionSurgical implant placed within the eye to elute travoprost	Drug	Travoprost Intraocular Implant, low elution
Timolol Maleate Ophthalmic Solution, 0.5%Instillation of one drop of timolol in the study eye twice daily	Drug	Timolol Maleate Ophthalmic Solution, 0.5%

Primary outcome

IOP (mmHg) Change From Baseline at Week 12
Time frame: 12 weeks
Change from baseline in IOP (measured in mmHg) at week 12. Negative values represent reductions in IOP from baseline.

Results and safety

Results posted to the registry on 9 Aug 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
Travoprost Intraocular Implant, High Elution	51	44
Travoprost Intraocular Implant, Low Elution	54	46
Timolol Maleate Ophthalmic Solution, 0.5%	49	45

Primary outcome: IOP (mmHg) Change From Baseline at Week 12

Time frame: 12 weeks. Mean (Standard Error). Unit: mmHg

Measure	Travoprost Intraocular Implant, High Elution n = 51	Travoprost Intraocular Implant, Low Elution n = 54	Timolol Maleate Ophthalmic Solution, 0.5% n = 49
Value	-8.3 (0.34)	-7.7 (0.26)	-7.5 (0.21)

Population analysed: intent-to-treat population

Adverse events

Time frame: overall study period of 36 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Travoprost Intraocular Implant, High Elution	4 of 51 (7.8%)	28 of 51 (54.9%)	0 of 51
Travoprost Intraocular Implant, Low Elution	9 of 54 (16.7%)	22 of 54 (40.7%)	2 of 54
Timolol Maleate Ophthalmic Solution, 0.5%	3 of 49 (6.1%)	14 of 49 (28.6%)	0 of 49

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 38060092Berdahl JP, Sarkisian SR Jr, Ang RE, Doan LV, Kothe AC, Usner DW, Katz LJ, Navratil T; Travoprost Intraocular Implant Study Group. Efficacy and Safety of the Travoprost Intraocular Implant in Reducing Topical IOP-Lowering Medication Burden in Patients with Open-Angle Glaucoma or Ocular Hypertension. Drugs. 2024 Jan;84(1):83-97. doi: 10.1007/s40265-023-01973-7. Epub 2023 Dec 7.
Individual participant dataSharing planned: No. The datasets generated during and/or analyzed during the current study are not publicly available at this time due to ongoing U.S. Food and Drug Administration review of a New Drug Application for the travoprost intraocular implant.

Related trials for Glaucoma Open-angle

Recruiting
A Study Evaluating the Safety and Efficacy of MINIject S+ in Subjects With Open Angle Glaucoma
Glaucoma
Active, not recruiting
OMNI 3.1 Surgical System in Subjects With Primary Open-Angle Glaucoma
Primary Open Angle Glaucoma
Not yet recruiting
Evaluation the Safety and Effectiveness of the GORE GDI in Adult Subjects With Primary Open-angle Glaucoma in Whom Previous Medical and Surgical Treatment Have Failed.
Glaucoma, Primary Open Angle
Active, not recruiting
Electrical Stimulation for the Treatment of Optic Neuropathies
Glaucoma, Glaucoma, Open-Angle
Not yet recruitingPhase 4
The Effect of Lumify™ on Ocular Redness, Intraocular Pressure, and Eyelid Position in Glaucoma Patients
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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?

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 1 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: 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 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 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 9 Aug 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?

IOP (mmHg) Change From Baseline at Week 12 (time frame: 12 weeks). 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 NCT02754596, 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.