Open Angle Glaucoma (OAG)Phase 4NCT07847073
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
A Phase 4 study testing Netarsudil 0.02% Ophthalmic Solution [RHOPRESSA] and Timolol Maleate 0.25% Ophthalmic Solution in people with Open Angle Glaucoma (OAG) and Glaucoma, run by Brett King at 1 site in United States.
Trial summary
The purpose of this study is to compare how two FDA-approved eye drops: netarsudil (Rhopressa) and timolol, protect nerve cells in the eye of adults with open-angle glaucoma. Both medications lower pressure inside the eye, but researchers want to learn if Rhopressa is more effective at slowing down or preventing the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open Angle Glaucoma (OAG), Glaucoma
- What is being tested?
- Netarsudil 0.02% Ophthalmic Solution [RHOPRESSA] and Timolol Maleate 0.25% Ophthalmic Solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Jan 2028
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All subjects will be 18 years of age or older
- Subjects must be diagnosed with open-angle glaucoma and have had an eye exam within the past year
- Subjects with glaucoma will have structural (optic nerve and retinal nerve fiber layer) and functional (visual field testing) defects consistent with the diagnosis of glaucoma
- Subjects will have a corrected acuity of 20/50 or better and be able to fixate
- Naïve to medication subjects or post washout IOP between 18 and 34 mmHg
- Spherical equivalent from +3 diopters to -6 diopters, with a cylinder of <-3 diopters
- Subject is willing and able to comply with the protocol requirements and to remain in the study for its full duration, including all scheduled visits and follow-up assessments
Who cannot join
- Subjects with a known intolerance to netarsudil ophthalmic solution
- Subjects with a known intolerance to, or contraindication for, timolol maleate
- Any subject whom the investigator determines to be at unacceptable risk for the washout or believes is unlikely to complete the study
- Subjects with retinal disease or optic neuropathies other than glaucoma that, in the opinion of the investigator, could confound the study assessments or outcome
- Female subjects who are pregnant, breastfeeding, or of childbearing age who are not sterile or using an acceptable method of contraception during the 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
Indiana University School Of Optometry
Bloomington, Indiana, 47405
Brett J King, OD, FAAO, Dipl AAO(Glaucoma), (812) 855-1344, kingbrj@iu.edu
Kaitlyn M Asher, CCRC, BS, 2194067487, kamasher@iu.edu
About this study
The purpose of this study is to compare how two FDA-approved eye drops: netarsudil (Rhopressa) and timolol, protect nerve cells in the eye of adults with open-angle glaucoma. Both medications lower pressure inside the eye, but researchers want to learn if Rhopressa is more effective at slowing down or preventing the loss of retinal ganglion cells. These cells are essential for sight because they carry visual signals from the eye to the brain.
Participants in this study will complete a total of 6 study visits over 12 months:
Read more
- Participants will spend 6 months using Rhopressa eye drops and 6 months using Timolol eye drops. The order of the two eye drops will be chosen randomly.
- At scheduled study visits, researchers will examine participants' eyes and measure eye pressure.
- Researchers will take detailed pictures of the back of the eye using a specialized high-resolution camera called adaptive optics optical coherence tomography (AO-OCT).
- Participants will also complete specialized visual field testing to measure eye function.
Researchers will count and track individual nerve cells over time to determine if one medication offers better protection against cell loss than the other.
Read the detailed description
Glaucoma is a chronic, progressive optic neuropathy characterized by functional and structural alterations, specifically the degeneration and loss of retinal ganglion cells (RGCs). Currently, the main modifiable factor for intervention is aimed at lowering intraocular pressure (IOP). While IOP reduction slows disease progression, it does not halt neurodegeneration. Rho kinase (ROCK) inhibitors have been reported to provide benefit in neurodegenerative diseases. Netarsudil ophthalmic solution (Rhopressa) is a ROCK inhibitor approved for the treatment and management of open-angle glaucoma that lowers IOP and has reported protective effects on neural tissue. However, previous attempts to illustrate true cell loss or protection using clinical instrumentation have not demonstrated an effect to date.
High-resolution retinal imaging based on adaptive optics optical coherence tomography (AO-OCT) enables direct visualization, tracking, and quantification of individual ganglion cell layer (GCL) somas in the living human eye. Leveraging the unique imaging capabilities and extraordinary sensitivity of ultra-high-speed AO-OCT, this study will test the hypothesis that treatment with netarsudil is more effective at reducing glaucomatous ganglion cell loss while producing comparable intraocular pressure reduction to that of the comparator.
This prospective, randomized, investigator-masked, cross-over pilot study will compare RGC survival rates between two treatment groups (Rhopressa and Timolol). Thirteen subjects with open-angle glaucoma will be recruited. Following a screening assessment and medication washout period based on drug class, eligible subjects are randomized 1:1 into two age-matched cohorts:
- Cohort 1: Receives Rhopressa (one drop once at night) for 6 months, then crosses over to receive Timolol 0.25% (one drop twice a day) for 6 months.
- Cohort 2: Receives Timolol 0.25% (one drop twice a day) for 6 months, then crosses over to receive Rhopressa (one drop once at night) for 6 months.
At Visit 2 (baseline), Visit 4 (6 months), and Visit 6 (12 months), subjects undergo imaging using the Indiana AO-OCT system along with Goldmann applanation tonometry, standard clinical OCT, and OCT-guided microperimetry (MP-3). AO-OCT imaging is performed at the same retinal regions surrounding arcuate defects to enable longitudinal cellular-level analysis. Primary and secondary endpoints evaluate differences in the rate of change of RGC soma density, individual RGC counts, and GCL thickness between treatment periods.
- Conditions
- Open Angle Glaucoma (OAG), Glaucoma
- Being tested
- Netarsudil 0.02% Ophthalmic Solution [RHOPRESSA], Timolol Maleate 0.25% Ophthalmic Solution
- Keywords
- glaucoma, rhopressa, ganglion cells, optometry, vision, IOP, eye pressure, timolol
- Medical subject headings
- Glaucoma, Open-Angle, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Netarsudil 0.02% Ophthalmic Solution [RHOPRESSA]Drug
Also called Rhopressa
Netarsudil ophthalmic solution (Rhopressa) is an FDA-approved Rho kinase inhibitor indicated for the treatment of ocular hypertension and open-angle glaucoma. In this study, participants will instill 1 drop of netarsudil 0.02% ophthalmic solution in the study eye once daily in the evening for 6 months.
Timolol Maleate 0.25% Ophthalmic SolutionDrug
Also called Timoptic
Timolol maleate ophthalmic solution is an FDA-approved non-selective beta-adrenergic receptor blocking agent indicated for the treatment of ocular hypertension and open-angle glaucoma. In this study, participants will instill 1 drop of timolol maleate 0.25% ophthalmic solution in the study eye twice daily (in the morning and evening) for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Rhopressa first, then Timolol | Experimental | Participants will instill netarsudil 0.02% (Rhopressa) ophthalmic solution (1 drop in the study eye once daily in the evening) for the first 6 months (Months 0-6). At the Month 6 visit, participants will cross over to instill timolol maleate 0.25% ophthalmic solution (1 drop in the study eye twice daily) for the remaining 6 months (Months 6-12). Receives: Drug: Netarsudil 0.02% Ophthalmic Solution [RHOPRESSA]; Drug: Timolol Maleate 0.25% Ophthalmic Solution |
| Timolol first, then Rhopressa | Experimental | Participants will instill timolol maleate 0.25% ophthalmic solution (1 drop in the study eye twice daily) for the first 6 months (Months 0-6). At the Month 6 visit, participants will cross over to instill netarsudil 0.02% (Rhopressa) ophthalmic solution (1 drop in the study eye once daily in the evening) for the remaining 6 months (Months 6-12). Receives: Drug: Netarsudil 0.02% Ophthalmic Solution [RHOPRESSA]; Drug: Timolol Maleate 0.25% Ophthalmic Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in GC soma density (cells/mm²)
Change in ganglion cell (GC) soma density during treatment with timolol versus netarsudil (Rhopressa)
Measured: Baseline, 6 months, and 12 months
Secondary outcomes (2)
Changes in GC soma counts (number of cells)
Changes in ganglion cell (GC) soma counts during treatment with timolol versus netarsudil (Rhopressa)
Measured: Baseline, 6 months, and 12 months
Changes in GCL thickness (micrometers (µm))
Changes in ganglion cell layer (GCL) thickness during treatment with timolol versus netarsudil (Rhopressa)
Measured: Baseline, 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open Angle Glaucoma (OAG)Studies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 13 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brett King
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Responsible party
- Sponsor-investigator, Brett King, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07847073
- Sponsor's protocol ID
- 32936
- Other IDs
- 17426-BJKing
- Status last verified
- Oct 2026
- First submitted
- 22 Sep 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
- ClinicalTrials.gov ID
- NCT07847073
- Acronym / sponsor ID
- 32936
- Conditions
- Open Angle Glaucoma (OAG), Glaucoma
- Keywords
- glaucoma, rhopressa, ganglion cells, optometry, vision, IOP, eye pressure, timolol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 13 participants (estimated)
- Lead sponsor
- Brett KingUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- Oct 2026 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 29 Sep 2026 (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 purpose of this study is to compare how two FDA-approved eye drops: netarsudil (Rhopressa) and timolol, protect nerve cells in the eye of adults with open-angle glaucoma. Both medications lower pressure inside the eye, but researchers want to learn if Rhopressa is more effective at slowing down or preventing the loss of retinal ganglion cells. These cells are essential for sight because they carry visual signals from the eye to the brain.
Participants in this study will complete a total of 6 study visits over 12 months:
- Participants will spend 6 months using Rhopressa eye drops and 6 months using Timolol eye drops. The order of the two eye drops will be chosen randomly.
- At scheduled study visits, researchers will examine participants' eyes and measure eye pressure.
- Researchers will take detailed pictures of the back of the eye using a specialized high-resolution camera called adaptive optics optical coherence tomography (AO-OCT).
- Participants will also complete specialized visual field testing to measure eye function.
Researchers will count and track individual nerve cells over time to determine if one medication offers better protection against cell loss than the other.
Detailed description
Glaucoma is a chronic, progressive optic neuropathy characterized by functional and structural alterations, specifically the degeneration and loss of retinal ganglion cells (RGCs). Currently, the main modifiable factor for intervention is aimed at lowering intraocular pressure (IOP). While IOP reduction slows disease progression, it does not halt neurodegeneration. Rho kinase (ROCK) inhibitors have been reported to provide benefit in neurodegenerative diseases. Netarsudil ophthalmic solution (Rhopressa) is a ROCK inhibitor approved for the treatment and management of open-angle glaucoma that lowers IOP and has reported protective effects on neural tissue. However, previous attempts to illustrate true cell loss or protection using clinical instrumentation have not demonstrated an effect to date.
High-resolution retinal imaging based on adaptive optics optical coherence tomography (AO-OCT) enables direct visualization, tracking, and quantification of individual ganglion cell layer (GCL) somas in the living human eye. Leveraging the unique imaging capabilities and extraordinary sensitivity of ultra-high-speed AO-OCT, this study will test the hypothesis that treatment with netarsudil is more effective at reducing glaucomatous ganglion cell loss while producing comparable intraocular pressure reduction to that of the comparator.
This prospective, randomized, investigator-masked, cross-over pilot study will compare RGC survival rates between two treatment groups (Rhopressa and Timolol). Thirteen subjects with open-angle glaucoma will be recruited. Following a screening assessment and medication washout period based on drug class, eligible subjects are randomized 1:1 into two age-matched cohorts:
- Cohort 1: Receives Rhopressa (one drop once at night) for 6 months, then crosses over to receive Timolol 0.25% (one drop twice a day) for 6 months.
- Cohort 2: Receives Timolol 0.25% (one drop twice a day) for 6 months, then crosses over to receive Rhopressa (one drop once at night) for 6 months.
At Visit 2 (baseline), Visit 4 (6 months), and Visit 6 (12 months), subjects undergo imaging using the Indiana AO-OCT system along with Goldmann applanation tonometry, standard clinical OCT, and OCT-guided microperimetry (MP-3). AO-OCT imaging is performed at the same retinal regions surrounding arcuate defects to enable longitudinal cellular-level analysis. Primary and secondary endpoints evaluate differences in the rate of change of RGC soma density, individual RGC counts, and GCL thickness between treatment periods.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rhopressa first, then Timolol | Experimental | Drug: Netarsudil 0.02% Ophthalmic Solution [RHOPRESSA], Drug: Timolol Maleate 0.25% Ophthalmic SolutionParticipants will instill netarsudil 0.02% (Rhopressa) ophthalmic solution (1 drop in the study eye once daily in the evening) for the first 6 months (Months 0-6). At the Month 6 visit, participants will cross over to instill timolol maleate 0.25% ophthalmic solution (1 drop in the study eye twice daily) for the remaining 6 months (Months 6-12). |
| Timolol first, then Rhopressa | Experimental | Drug: Netarsudil 0.02% Ophthalmic Solution [RHOPRESSA], Drug: Timolol Maleate 0.25% Ophthalmic SolutionParticipants will instill timolol maleate 0.25% ophthalmic solution (1 drop in the study eye twice daily) for the first 6 months (Months 0-6). At the Month 6 visit, participants will cross over to instill netarsudil 0.02% (Rhopressa) ophthalmic solution (1 drop in the study eye once daily in the evening) for the remaining 6 months (Months 6-12). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- All subjects will be 18 years of age or older
- Subjects must be diagnosed with open-angle glaucoma and have had an eye exam within the past year
- Subjects with glaucoma will have structural (optic nerve and retinal nerve fiber layer) and functional (visual field testing) defects consistent with the diagnosis of glaucoma
- Subjects will have a corrected acuity of 20/50 or better and be able to fixate
- Naïve to medication subjects or post washout IOP between 18 and 34 mmHg
Key exclusion criteria (5 listed)
- Subjects with a known intolerance to netarsudil ophthalmic solution
- Subjects with a known intolerance to, or contraindication for, timolol maleate
- Any subject whom the investigator determines to be at unacceptable risk for the washout or believes is unlikely to complete the study
- Subjects with retinal disease or optic neuropathies other than glaucoma that, in the opinion of the investigator, could confound the study assessments or outcome
- Female subjects who are pregnant, breastfeeding, or of childbearing age who are not sterile or using an acceptable method of contraception during the study
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 |
|---|---|---|
| Netarsudil 0.02% Ophthalmic Solution [RHOPRESSA]Also: RhopressaNetarsudil ophthalmic solution (Rhopressa) is an FDA-approved Rho kinase inhibitor indicated for the treatment of ocular hypertension and open-angle glaucoma. In this study, participants will instill 1 drop of netarsudil 0.02% ophthalmic solution in the study eye once daily in the evening for 6 months. | Drug | Rhopressa first, then Timolol, Timolol first, then Rhopressa |
| Timolol Maleate 0.25% Ophthalmic SolutionAlso: TimopticTimolol maleate ophthalmic solution is an FDA-approved non-selective beta-adrenergic receptor blocking agent indicated for the treatment of ocular hypertension and open-angle glaucoma. In this study, participants will instill 1 drop of timolol maleate 0.25% ophthalmic solution in the study eye twice daily (in the morning and evening) for 6 months. | Drug | Rhopressa first, then Timolol, Timolol first, then Rhopressa |
Primary outcome
Change in GC soma density (cells/mm²)
Time frame: Baseline, 6 months, and 12 months
Change in ganglion cell (GC) soma density during treatment with timolol versus netarsudil (Rhopressa)
2 secondary outcomes
Changes in GC soma counts (number of cells)
Time frame: Baseline, 6 months, and 12 months
Changes in GCL thickness (micrometers (µm))
Time frame: Baseline, 6 months, and 12 months
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 28 Oct 2026.
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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 Netarsudil 0.02% Ophthalmic Solution [RHOPRESSA] and Timolol Maleate 0.25% Ophthalmic Solution in people with Open Angle Glaucoma (OAG) and Glaucoma, run by Brett King 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 7 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: looking for participants now, as of the sponsor's last update on 28 Oct 2026. 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 Brett J King, OD, FAAO, Dipl AAO (Glaucoma) ((812) 855-1344, kingbrj@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in GC soma density (cells/mm²) (time frame: Baseline, 6 months, and 12 months). 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 28 Oct 2026.