GlaucomaPhase 4NCT07209410
Evaluating Injection With the Use of Brimonidine Tartrate Ophthalmic 0.025% on Patients Using Netarsudil 0.02%/Latanoprost 0.005% to Treat Glaucoma
A Phase 4 study testing Brimonidine Tartrate Ophthalmic 0.025% in people with Glaucoma, run by Insight Eyecare Specialties, Inc. dba Vision Source Eyecare, at 1 site in United States.
Trial summary
To evaluate the effect of brimonidine tartrate 0.025% on conjunctival hyperemia in patients treated with netarsudil 0.02%/latanoprost 0.005% mono-therapy for intraocular pressure lowering. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Glaucoma
- What is being tested?
- Brimonidine Tartrate Ophthalmic 0.025%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2025to 1 Jun 2027
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Adult patients 18-65 years old diagnosed with open-angle glaucoma or ocular hypertension.
- 2. Currently on netarsudil 0.02%/latanoprost 0.005% monotherapy for a minimum of 2-6 weeks.
- 3. Able to move from current topical glaucoma treatment to netarsudil 0.02%/latanoprost 0.005% for a minimum of 4 weeks or longer based on FDA recommended washout per drug classification prior to Visit 3.
- 4. Experience conjunctival redness as graded on the Efron scale of at least grade 2 after minimum of 4 weeks on netarsudil 0.02%/latanoprost 0.005% mono-therapy or longer based on recommended washout per drug classification 4. Have a best corrected Visual Acuity by Snellen chart of 20/30 or better in study eye.
- 5. Are willing and able to self-administer or have an able person available to assist with administration of study drug.
- Willing and able to comply with study procedures and attend follow-up visits.
Who cannot join
- Allergy or hypersensitivity to brimonidine or other components of brimonidine tartrate 0.025% or netarsudil 0.02%/latanoprost 0.005%.
- Use of any other topical ocular medications.
- Active ocular infection, inflammation unrelated to glaucoma therapy, uveitis, iritis or congenital aphakia.
- Have pterygium/pinguecula, chemosis, episcleritis, scleritis (or any condition that may affect hyperemia grading) in the opinion of the investigator
- Have moderate or severe dry eyes.
- Pregnant, plan to become pregnant or breastfeeding.
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- Concurrent or past use in the last 90 days of vasoconstrictive ocular drops other than brimondine 0.025%
- Have undergone previous incision IOP lowering surgeries.
- Have undergone previous laser surgery for glaucoma (selective laser trabeculoplasty (SLT) or argon laser trabeculoplasty (ALT)), or microinvasive glaucoma surgery (MIGS) with 6 months of screening.
- Have had intraocular or per-ocular surgery within the past 3 months.
- Advanced glaucoma or c/d ratio greater than 0.8. Are non-responsive to topical treatment with netarsudil 0.02%/latanoprost 0.005%.
- In the judgement of the investigator, have previous or currently active clinically significant systemic or ocular disease in either eye that could affect study outcomes.
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
Vision Source
Kansas City, Missouri, 64111
Megan Hefter Research Coordinator, 816-531-9100, mh@vseyecare.com
About this study
Official title: Impact of Brimonidine Tartrate Ophthalmic 0.025% on Patients Using Netarsudil 0.02%/Latanoprost 0.005% to Treat Glaucoma
To evaluate the effect of brimonidine tartrate 0.025% on conjunctival hyperemia in patients treated with netarsudil 0.02%/latanoprost 0.005% mono-therapy for intraocular pressure lowering.
- Conditions
- Glaucoma
- Being tested
- Brimonidine Tartrate Ophthalmic 0.025%
- Keywords
- Glaucoma, Hyperemia
- Medical subject headings
- Glaucoma, Hyperemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brimonidine Tartrate Ophthalmic 0.025%Drug
Lumify is an approved eye drop to minimize ocular hyperemia.
| Study group | Role | What they receive |
|---|---|---|
| Brimonidine Tartrate | Experimental | Patients experiencing hyperemia greater than grade 2 on Efron scale will receive brimonidine tartrate (Lumify). Photo documentation of hyperemia and patient satisfaction questionnaires will be administered. Receives: Drug: Brimonidine Tartrate Ophthalmic 0.025% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effron Grading scale of ocular redness
Measuring Ocular Hyperemia and injection.
This is measured on Scale 0-4 0- Normal
- Trace
- Mild
- Moderate
- Severe
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start1 Nov 2025
- Primary completion15 Dec 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insight Eyecare Specialties, Inc. dba Vision Source Eyecare,
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Crystal Remington, Insight Eyecare Specialties, Inc. dba Vision Source Eyecare,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07209410
- Sponsor's protocol ID
- VSE002
- Status last verified
- Nov 2025
- First submitted
- 1 Oct 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Brimonidine Tartrate Ophthalmic 0.025% on Patients Using Netarsudil 0.02%/Latanoprost 0.005% to Treat Glaucoma
- ClinicalTrials.gov ID
- NCT07209410
- Acronym / sponsor ID
- VSE002
- Conditions
- Glaucoma
- Keywords
- Glaucoma, Hyperemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Insight Eyecare Specialties, Inc. dba Vision Source Eyecare,University, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 7 Oct 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.
To evaluate the effect of brimonidine tartrate 0.025% on conjunctival hyperemia in patients treated with netarsudil 0.02%/latanoprost 0.005% mono-therapy for intraocular pressure lowering.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brimonidine Tartrate | Experimental | Drug: Brimonidine Tartrate Ophthalmic 0.025%Patients experiencing hyperemia greater than grade 2 on Efron scale will receive brimonidine tartrate (Lumify). Photo documentation of hyperemia and patient satisfaction questionnaires will be administered. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 1. Adult patients 18-65 years old diagnosed with open-angle glaucoma or ocular hypertension.
- 2. Currently on netarsudil 0.02%/latanoprost 0.005% monotherapy for a minimum of 2-6 weeks.
- 3. Able to move from current topical glaucoma treatment to netarsudil 0.02%/latanoprost 0.005% for a minimum of 4 weeks or longer based on FDA recommended washout per drug classification prior to Visit 3.
- 4. Experience conjunctival redness as graded on the Efron scale of at least grade 2 after minimum of 4 weeks on netarsudil 0.02%/latanoprost 0.005% mono-therapy or longer based on recommended washout per drug classification 4. Have a best corrected Visual Acuity by Snellen chart of 20/30 or better in study eye.
- 5. Are willing and able to self-administer or have an able person available to assist with administration of study drug.
Key exclusion criteria (12 listed)
- Allergy or hypersensitivity to brimonidine or other components of brimonidine tartrate 0.025% or netarsudil 0.02%/latanoprost 0.005%.
- Use of any other topical ocular medications.
- Active ocular infection, inflammation unrelated to glaucoma therapy, uveitis, iritis or congenital aphakia.
- Have pterygium/pinguecula, chemosis, episcleritis, scleritis (or any condition that may affect hyperemia grading) in the opinion of the investigator
- Have moderate or severe dry eyes.
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 |
|---|---|---|
| Brimonidine Tartrate Ophthalmic 0.025%Lumify is an approved eye drop to minimize ocular hyperemia. | Drug | Brimonidine Tartrate |
Primary outcome
Effron Grading scale of ocular redness
Time frame: 2 weeks
Measuring Ocular Hyperemia and injection. This is measured on Scale 0-4 0- Normal 1. Trace 2. Mild 3. Moderate 4. Severe
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 18 Nov 2025.
- Individual participant dataSharing planned: Undecided
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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.
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 Brimonidine Tartrate Ophthalmic 0.025% in people with Glaucoma, run by Insight Eyecare Specialties, Inc. dba Vision Source Eyecare, 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 6 inclusion and 12 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 18 Nov 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 Crystal Remington Optometrist, OD (816-531-9100, drremington@vseyecare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effron Grading scale of ocular redness (time frame: 2 weeks). 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 18 Nov 2025.