Open Angle GlaucomaPhase 4NCT06883123
Efficacy of Simbrinza and Rocklatan vs Cosopt and Latanoprost
A Phase 4 study testing Simbrinza 0.2%-1% Ophthalmic Suspension, Rocklatan 0.02%-0.005% Ophthalmic Solution and Cosopt PF 2%-0.5% Ophthalmic Solution in people with Open Angle Glaucoma, run by Prairie Eye Center at 1 site in United States.
Trial summary
A randomized, multi-site, parallel-group, prospective study of patients who are adults with a diagnosis of mild to moderate open-angle glaucoma (OAG), currently on an on-label use of combination topical medication of Cosopt and Latanoprost for a minimum of 1 month. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Open Angle Glaucoma
- What is being tested?
- Simbrinza 0.2%-1% Ophthalmic Suspension, Rocklatan 0.02%-0.005% Ophthalmic Solution and Cosopt PF 2%-0.5% Ophthalmic Solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2025to 1 Apr 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged Eighteen (18) years and older with a diagnosis of mild to moderate open-angle glaucoma (OAG), currently on an on-label use of combination topical medication of Cosopt and Latanoprost for a minimum of 1 month. Evidence of optic nerve damage will be based on AAO Preferred Practice Patterns guidelines using either or both of the following:
- Optic disc or retinal nerve fiber layer (RNFL) structural abnormalities
- Diffuse or focal narrowing, or notching, of the optic disc rim, especially at the inferior or superior poles, which forms the basis for the ISNT rule
- Progressive narrowing of the neuroretinal rim with an associated increase in cupping of the optic disc
- Diffuse or localized abnormalities of the parapapillary RNFL, especially at the inferior or superior poles
- Disc rim, parapapillary RNFL, or lamina cribrosa hemorrhages
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- Optic disc neural rim asymmetry of the two eyes consistent with loss of neural tissue
- Large extent of parapapillary atrophy
- Reliable and reproducible visual field abnormality considered a valid representation of the subject's functional status
- Visual field damage consistent with RNFL damage (e.g. nasal step, arcuate field defect, or paracentral depression in clusters of test sites)
- Visual field loss across the horizontal midline in one hemifield that exceeds loss in the opposite hemifield (in early/ moderate cases)
- Absence of other known explanations (e.g. optic disc drusen, optic nerve pit)
- Mean diurnal IOP ≥ 18 mmHg and < 28 mmHg at baseline in at least one eye with an inter-eye IOP difference < 5 mmHg.
- A central corneal thickness (CCT) within the range of 450-650 µm
Who cannot join
- Patients with prior ocular procedures or intraocular surgery within 1 year prior to baseline (e.g. cataract surgery).
- Patients with prior history of glaucoma surgeries or laser treatment except patients with history of SLT >1 yr prior to baseline.
- Contraindications or known hypersensitivity to any or all the study medications including Rocklatan, Simbrinza, Cosopt and Latanoprost or related class of drugs.
- Patients with known history or presence of uncontrolled systemic diseases including diseases that, in investigator's opinion, may make it unsafe or undesirable for the subject to participate in the study and/ or limit adherence.
- Patients with known history or presence of significant ocular diseases including corneal diseases, dystrophies or abnormalities that would prevent accurate IOP readings with GAT.
- Patients with a history of uncontrolled IOP with the combination of either Rocklatan + Simbrinza or Cosopt + Latanoprost dual therapy.
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- Significant ocular surface findings (e.g. hyperemia, irritation) found during slit lamp examination that might affect the study.
- Chronic use of any systemic medication for chronic diseases that may affect IOP.
- Subjects who are pregnant, lactating or planning a pregnancy.
- Any condition in the opinion in the investigator that would potentially confound the results of this study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Prairie Eye Center
Springfield, Illinois, 62704
Jennifer Lyons, 217-257-3102, jenniferlyons37@gmail.com
Sanda Yeh, MD
About this study
Official title: Efficacy and Tolerability of Simbrinza and Rocklatan vs. Cosopt
A randomized, multi-site, parallel-group, prospective study of patients who are adults with a diagnosis of mild to moderate open-angle glaucoma (OAG), currently on an on-label use of combination topical medication of Cosopt and Latanoprost for a minimum of 1 month.
- Conditions
- Open Angle Glaucoma
- Being tested
- Simbrinza 0.2%-1% Ophthalmic Suspension, Rocklatan 0.02%-0.005% Ophthalmic Solution, Cosopt PF 2%-0.5% Ophthalmic Solution, Latanoprost 0.005% Ophthalmic Solution
- 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.
Simbrinza 0.2%-1% Ophthalmic SuspensionDrug
brinzolamide and brimonidine tartrate
Rocklatan 0.02%-0.005% Ophthalmic SolutionDrug
netarsudil and latanoprost
Cosopt PF 2%-0.5% Ophthalmic SolutionDrug
dorzolamide hydrochloride and timolol maleate
Latanoprost 0.005% Ophthalmic SolutionDrug
Latanoprost
| Study group | Role | What they receive |
|---|---|---|
| Simbrinza and Rocklatan | Experimental | SIMBRINZA (brinzolamide and brimonidine tartrate) 1%/0.2% ROCKLATAN (netarsudil and latanoprost) 0.02%/0.005% Receives: Drug: Simbrinza 0.2%-1% Ophthalmic Suspension; Drug: Rocklatan 0.02%-0.005% Ophthalmic Solution |
| Cosopt and Latanoprost | Active comparator | COSOPT (dorzolamide hydrochloride and timolol maleate) 2%/0.5% Latanoprost 0.005% Receives: Drug: Cosopt PF 2%-0.5% Ophthalmic Solution; Drug: Latanoprost 0.005% Ophthalmic Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in mean diurnal IOP
Mean diurnal IOP is determined as the average IOP measured at 8:30am, 12:00pm and 3:30pm
Measured: from baseline at week 8
Secondary outcomes (3)
Mean decrease in IOP at 8:30am
Measured: from baseline at week 8
Mean decrease in IOP at 12:00pm
Measured: from baseline at week 8
Mean decrease in IOP at 4:30pm
Measured: from baseline at week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start14 May 2025
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Apr 2026 (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.
- 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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prairie Eye Center
- Sponsor type
- University, hospital or other
- Collaborators
- Sengi
- Responsible party
- Sponsor
- Investigators
- Sandra Yeh, MD, Principal investigator, Prairie Eye Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06883123
- Sponsor's protocol ID
- SY-25-01
- Status last verified
- May 2025
- First submitted
- 12 Mar 2025
- Last updated
- 15 May 2025
- 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 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Tolerability of Simbrinza and Rocklatan vs. Cosopt
- ClinicalTrials.gov ID
- NCT06883123
- Acronym / sponsor ID
- SY-25-01
- Conditions
- Open Angle Glaucoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Prairie Eye CenterUniversity, hospital or other
- Collaborators
- Sengi
- Study start
- 14 May 2025 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 19 Mar 2025 (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.
A randomized, multi-site, parallel-group, prospective study of patients who are adults with a diagnosis of mild to moderate open-angle glaucoma (OAG), currently on an on-label use of combination topical medication of Cosopt and Latanoprost for a minimum of 1 month.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simbrinza and Rocklatan | Experimental | Drug: Simbrinza 0.2%-1% Ophthalmic Suspension, Drug: Rocklatan 0.02%-0.005% Ophthalmic SolutionSIMBRINZA (brinzolamide and brimonidine tartrate) 1%/0.2% ROCKLATAN (netarsudil and latanoprost) 0.02%/0.005% |
| Cosopt and Latanoprost | Active comparator | Drug: Cosopt PF 2%-0.5% Ophthalmic Solution, Drug: Latanoprost 0.005% Ophthalmic SolutionCOSOPT (dorzolamide hydrochloride and timolol maleate) 2%/0.5% Latanoprost 0.005% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Adults aged Eighteen (18) years and older with a diagnosis of mild to moderate open-angle glaucoma (OAG), currently on an on-label use of combination topical medication of Cosopt and Latanoprost for a minimum of 1 month. Evidence of optic nerve damage will be based on AAO Preferred Practice Patterns guidelines using either or both of the following:
- Optic disc or retinal nerve fiber layer (RNFL) structural abnormalities
- Diffuse or focal narrowing, or notching, of the optic disc rim, especially at the inferior or superior poles, which forms the basis for the ISNT rule
- Progressive narrowing of the neuroretinal rim with an associated increase in cupping of the optic disc
- Diffuse or localized abnormalities of the parapapillary RNFL, especially at the inferior or superior poles
Key exclusion criteria (10 listed)
- Patients with prior ocular procedures or intraocular surgery within 1 year prior to baseline (e.g. cataract surgery).
- Patients with prior history of glaucoma surgeries or laser treatment except patients with history of SLT >1 yr prior to baseline.
- Contraindications or known hypersensitivity to any or all the study medications including Rocklatan, Simbrinza, Cosopt and Latanoprost or related class of drugs.
- Patients with known history or presence of uncontrolled systemic diseases including diseases that, in investigator's opinion, may make it unsafe or undesirable for the subject to participate in the study and/ or limit adherence.
- Patients with known history or presence of significant ocular diseases including corneal diseases, dystrophies or abnormalities that would prevent accurate IOP readings with GAT.
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 |
|---|---|---|
| Simbrinza 0.2%-1% Ophthalmic Suspensionbrinzolamide and brimonidine tartrate | Drug | Simbrinza and Rocklatan |
| Rocklatan 0.02%-0.005% Ophthalmic Solutionnetarsudil and latanoprost | Drug | Simbrinza and Rocklatan |
| Cosopt PF 2%-0.5% Ophthalmic Solutiondorzolamide hydrochloride and timolol maleate | Drug | Cosopt and Latanoprost |
| Latanoprost 0.005% Ophthalmic SolutionLatanoprost | Drug | Cosopt and Latanoprost |
Primary outcome
Decrease in mean diurnal IOP
Time frame: from baseline at week 8
Mean diurnal IOP is determined as the average IOP measured at 8:30am, 12:00pm and 3:30pm
3 secondary outcomes
Mean decrease in IOP at 8:30am
Time frame: from baseline at week 8
Mean decrease in IOP at 12:00pm
Time frame: from baseline at week 8
Mean decrease in IOP at 4:30pm
Time frame: from baseline at week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- 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.
Sandra Yeh, MD principal investigator
Prairie Eye Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Simbrinza 0.2%-1% Ophthalmic Suspension, Rocklatan 0.02%-0.005% Ophthalmic Solution and Cosopt PF 2%-0.5% Ophthalmic Solution in people with Open Angle Glaucoma, run by Prairie Eye Center 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 14 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 15 May 2025. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Lyons (217-257-3102, jenniferlyons37@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease in mean diurnal IOP (time frame: from baseline at week 8). 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 15 May 2025.