Open Angle GlaucomaPhase 2NCT06152861
Travoprost Ophthalmic Topical Cream for Open-angle Glaucoma or Ocular Hypertension
A Phase 2 study testing Travoprost Ophthalmic Topical Cream low-dose, Travoprost Ophthalmic Topical Cream mid-dose and Travoprost Ophthalmic Topical Cream high-dose in people with Open Angle Glaucoma and Ocular Hypertension, run by Glaukos Corporation at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn about the safety of Travoprost Ophthalmic Topical Cream and how well it works in lowering high intraocular pressure (IOP) in patients 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
- Open Angle Glaucoma, Ocular Hypertension
- What is being tested?
- Travoprost Ophthalmic Topical Cream low-dose, Travoprost Ophthalmic Topical Cream mid-dose and Travoprost Ophthalmic Topical Cream high-dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2023to Aug 2024
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, 18 years of age or older at the Screening Visit;
- Willing and able to provide written informed consent on the IRB/IEC-approved informed consent form;
- Diagnosis of OAG (including pigmentary and pseudoexfoliative) or OHT in both eyes;
- Qualifying IOP in the study eye;
- Best-corrected visual acuity of approximately 20/80 Snellen in each eye
Who cannot join
- Sensitivity or allergy to travoprost or timolol;
- Bronchial asthma, a history of bronchial asthma, or severe chronic obstructive pulmonary disease;
- History of or current sinus bradycardia, second- or third-degree atrioventricular block, overt cardiac failure, or cardiogenic shock;
- History of cerebrovascular insufficiency;
- Any form of glaucoma other than open-angle glaucoma
- Advanced visual field loss or cup-to-disc ratio of 0.8 or greater
- Non-qualifying prior surgeries or procedures in either eye
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Glaukos Clinical Study Site
Newport Beach, California, 92663
Glaukos Study Manager, 949-367-9600, PBraswell@glaukos.com
About this study
Official title: Multicenter, Randomized, Double-Masked, Active-Controlled, Parallel Group Phase 2 Trial Evaluating the Safety and Efficacy of Travoprost Ophthalmic Topical Cream in Subjects With Open-angle Glaucoma or Ocular Hypertension
The goal of this clinical trial is to learn about the safety of Travoprost Ophthalmic Topical Cream and how well it works in lowering high intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).
A low dose, medium dose and high dose of Travoprost Ophthalmic Topical Cream will be compared to timolol maleate ophthalmic solution, 0.5% and to travoprost ophthalmic solution, 0.004%.
- Conditions
- Open Angle Glaucoma, Ocular Hypertension
- Being tested
- Travoprost Ophthalmic Topical Cream low-dose, Travoprost Ophthalmic Topical Cream mid-dose, Travoprost Ophthalmic Topical Cream high-dose, Timolol maleate ophthalmic solution, 0.5%, Travoprost Ophthalmic Solution, 0.004%
- 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 Ophthalmic Topical Cream low-doseDrug
travoprost ophthalmic topical cream low-dose once daily in the evening to both eyes
Travoprost Ophthalmic Topical Cream mid-doseDrug
travoprost ophthalmic topical cream mid-dose once daily in the evening to both eyes
Travoprost Ophthalmic Topical Cream high-doseDrug
travoprost ophthalmic topical cream high-dose once daily in the evening to both eyes
Timolol maleate ophthalmic solution, 0.5%Drug
timolol maleate ophthalmic solution, 0.5% twice daily (morning \& evening) to both eyes
Travoprost Ophthalmic Solution, 0.004%Drug
travoprost ophthalmic solution, 0.004% once daily in the evening to both eyes
| Study group | Role | What they receive |
|---|---|---|
| Travoprost Ophthalmic Topical Cream low-dose | Experimental | Travoprost Ophthalmic Topical Cream low-dose administered once-daily in the evening for 28 days Receives: Drug: Travoprost Ophthalmic Topical Cream low-dose |
| Travoprost Ophthalmic Topical Cream mid-dose | Experimental | Travoprost Ophthalmic Topical Cream mid-dose administered once-daily in the evening for 28 days Receives: Drug: Travoprost Ophthalmic Topical Cream mid-dose |
| Travoprost Ophthalmic Topical Cream high-dose | Experimental | Travoprost Ophthalmic Topical Cream high-dose administered once-daily in the evening for 28 days Receives: Drug: Travoprost Ophthalmic Topical Cream high-dose |
| Timolol maleate ophthalmic solution, 0.5% | Active comparator | Timolol maleate ophthalmic solution, 0.5% administered twice daily, morning and evening, for 28 days Receives: Drug: Timolol maleate ophthalmic solution, 0.5% |
| Travoprost ophthalmic solution, 0.004% | Active comparator | Travoprost ophthalmic solution, 0.004% administered once daily in the evening for 28 days Receives: Drug: Travoprost Ophthalmic Solution, 0.004% |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline in mean diurnal IOP in the study eye
Day 29 mean diurnal IOP minus Baseline mean diurnal IOP in the study eye
Measured: Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2023
- Study start15 Nov 2023
- Primary completionAug 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 250 participants (estimated)
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
- NCT06152861
- Sponsor's protocol ID
- GLK-311-01
- Status last verified
- Nov 2023
- First submitted
- 22 Nov 2023
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Double-Masked, Active-Controlled, Parallel Group Phase 2 Trial Evaluating the Safety and Efficacy of Travoprost Ophthalmic Topical Cream in Subjects With Open-angle Glaucoma or Ocular Hypertension
- ClinicalTrials.gov ID
- NCT06152861
- Acronym / sponsor ID
- GLK-311-01
- Conditions
- Open Angle Glaucoma, Ocular Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Glaukos CorporationIndustry (pharma, biotech, devices)
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 1 Dec 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.
The goal of this clinical trial is to learn about the safety of Travoprost Ophthalmic Topical Cream and how well it works in lowering high intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).
A low dose, medium dose and high dose of Travoprost Ophthalmic Topical Cream will be compared to timolol maleate ophthalmic solution, 0.5% and to travoprost ophthalmic solution, 0.004%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Travoprost Ophthalmic Topical Cream low-dose | Experimental | Drug: Travoprost Ophthalmic Topical Cream low-doseTravoprost Ophthalmic Topical Cream low-dose administered once-daily in the evening for 28 days |
| Travoprost Ophthalmic Topical Cream mid-dose | Experimental | Drug: Travoprost Ophthalmic Topical Cream mid-doseTravoprost Ophthalmic Topical Cream mid-dose administered once-daily in the evening for 28 days |
| Travoprost Ophthalmic Topical Cream high-dose | Experimental | Drug: Travoprost Ophthalmic Topical Cream high-doseTravoprost Ophthalmic Topical Cream high-dose administered once-daily in the evening for 28 days |
| Timolol maleate ophthalmic solution, 0.5% | Active comparator | Drug: Timolol maleate ophthalmic solution, 0.5%Timolol maleate ophthalmic solution, 0.5% administered twice daily, morning and evening, for 28 days |
| Travoprost ophthalmic solution, 0.004% | Active comparator | Drug: Travoprost Ophthalmic Solution, 0.004%Travoprost ophthalmic solution, 0.004% administered once daily in the evening for 28 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female, 18 years of age or older at the Screening Visit;
- Willing and able to provide written informed consent on the IRB/IEC-approved informed consent form;
- Diagnosis of OAG (including pigmentary and pseudoexfoliative) or OHT in both eyes;
- Qualifying IOP in the study eye;
- Best-corrected visual acuity of approximately 20/80 Snellen in each eye
Key exclusion criteria (7 listed)
- Sensitivity or allergy to travoprost or timolol;
- Bronchial asthma, a history of bronchial asthma, or severe chronic obstructive pulmonary disease;
- History of or current sinus bradycardia, second- or third-degree atrioventricular block, overt cardiac failure, or cardiogenic shock;
- History of cerebrovascular insufficiency;
- Any form of glaucoma other than open-angle 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 |
|---|---|---|
| Travoprost Ophthalmic Topical Cream low-dosetravoprost ophthalmic topical cream low-dose once daily in the evening to both eyes | Drug | Travoprost Ophthalmic Topical Cream low-dose |
| Travoprost Ophthalmic Topical Cream mid-dosetravoprost ophthalmic topical cream mid-dose once daily in the evening to both eyes | Drug | Travoprost Ophthalmic Topical Cream mid-dose |
| Travoprost Ophthalmic Topical Cream high-dosetravoprost ophthalmic topical cream high-dose once daily in the evening to both eyes | Drug | Travoprost Ophthalmic Topical Cream high-dose |
| Timolol maleate ophthalmic solution, 0.5%timolol maleate ophthalmic solution, 0.5% twice daily (morning \& evening) to both eyes | Drug | Timolol maleate ophthalmic solution, 0.5% |
| Travoprost Ophthalmic Solution, 0.004%travoprost ophthalmic solution, 0.004% once daily in the evening to both eyes | Drug | Travoprost ophthalmic solution, 0.004% |
Primary outcome
change from baseline in mean diurnal IOP in the study eye
Time frame: Day 29
Day 29 mean diurnal IOP minus Baseline mean diurnal IOP in the study eye
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
- 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 2 study testing Travoprost Ophthalmic Topical Cream low-dose, Travoprost Ophthalmic Topical Cream mid-dose and Travoprost Ophthalmic Topical Cream high-dose in people with Open Angle Glaucoma 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 5 inclusion and 7 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 6 Dec 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Study Clinical Trial Associate (949-367-9600, SVea@glaukos.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline in mean diurnal IOP in the study eye (time frame: Day 29). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Dec 2023.