Primary Open Angle Glaucoma or Ocular HypertensionPhase 4NCT06865144
Effect of Rhopressa on Intraocular Pressure (IOP) in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension Post-SLT
A Phase 4 study testing Netarsudil ophthalmic solution 0.02% and Artificial tears in people with Primary Open Angle Glaucoma or Ocular Hypertension, run by East Coast Institute for Research at 1 site in United States.
Trial summary
The purpose of this study is to collect data about how Rhopressa affects IOP in patients who have had an SLT procedure in both eyes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Open Angle Glaucoma or Ocular Hypertension
- What is being tested?
- Netarsudil ophthalmic solution 0.02% and Artificial tears
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jun 2025to 1 Sep 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Documented diagnosis of bilateral POAG or ocular hypertension as determined by the investigator based on medical record review.
- At Screening (V1), the subject completed SLT in both the eyes within the last 90 days.
- Mean diurnal IOP of 16 to 28 mmHg at Randomization (V2 )
- At Randomization (V2), in the opinion of the investigator, subject may benefit from additional IOP reduction in the study eye and is a candidate for treatment with Rhopressa
- At Randomization (V2), if treated with IOP-lowering medication(s) in either eye prior to SLT, subject has completed the minimum washout period for the medication(s) (see Table 1)
- If female, subject is either incapable of pregnancy (e.g., history of bilateral oophorectomy, hysterectomy, bilateral tubal ligation) or post-menopausal (amenorrheic for at least 2 years) or will use an effective (e.g., double barrier) method of birth control for the duration of the study
Who cannot join
- History of more than one treatment with SLT in either eye
- Unable or unwilling to discontinue current IOP-lowering medication(s), if applicable
- Prior or current treatment with a rho kinase inhibitor
- Prior microinvasive glaucoma surgery (MIGS)
- Advanced stage of glaucoma, as determined by the investigator based on medical record review
- Any condition that prevents reliable applanation tonometry in either eye (e.g., significant corneal surface abnormalities, scars, keratoconus)
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- Previous or currently active corneal disease that, in the opinion of the investigator, could affect the study outcomes
- Active or recurrent intraocular infection, inflammation, iritis or uveitis
- Retinal disease (e.g., diabetic retinopathy, macular degeneration, central retinal vein or artery occlusion, macular edema)
- Intraocular injection performed ≤ 6 months prior to Screening (V1)
- Anticipated use of any topical ocular steroids and/or topical ocular nonsteroidal anti-inflammatory drugs (NSAID) during the study period
- Current participation in any drug or device clinical investigation, receipt of investigational drug within 6 drug half-lives of Screening (V1), or any previous placement of an investigational device.
- Any condition in the opinion of the investigator that would potentially confound the results of this study
Trial locations and contacts
1 site in 1 country.
United States1 site
East Coast Institute for Research at Florida Eye Specialists
Jacksonville, Florida, 32256
About this study
Official title: Prospective, Randomized, Double- Masked Study to Evaluate the Effect of Rhopressa Versus Placebo on Intraocular Pressure (IOP) in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension Post-Selective Laser Trabeculoplasty (SLT)
The purpose of this study is to collect data about how Rhopressa affects IOP in patients who have had an SLT procedure in both eyes.
Read the detailed description
This is a prospective, randomized, double-masked, placebo controlled (artificial tears), single center study. The study population will include seventy (n=70) subjects with POAG or ocular hypertension who have undergone SLT and may benefit from additional IOP reduction. If individuals are a candidate for treatment with Rhopressa (netarsudil) 0.02% ophthalmic solution post-SLT, they can potentially be included in the trial. The study duration per subject is expected to be 6 weeks (or up to 12 weeks if washout is required for previous IOP lowering treatment) with three scheduled study visits.
While both Rhopressa and 360 degrees SLT primarily target the trabecular meshwork, potential synergistic effects of the two therapies on conventional aqueous outflow are not completely understood. This study will determine whether initiation of Rhopressa post-360 degrees SLT provides greater IOP reduction than 360 degrees SLT alone. This information will aid healthcare providers in selecting the best approach to management of IOP in patients who have recently undergone 360 degrees SLT and may benefit from additional IOP reduction.
- Being tested
- Netarsudil ophthalmic solution 0.02%, Artificial tears
- Keywords
- primary open angle glaucoma, ocular hypertension, SLT, POAG, Selective Laser Trabeculoplasty, Rhopressa, netarsudil
- 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.
Netarsudil ophthalmic solution 0.02%Drug
Also called Rhopressa
Apply one drop in each eye every evening
Artificial tearsDrug
Apply one drop in each eye every evening
| Study group | Role | What they receive |
|---|---|---|
| Rhopressa | Experimental | Not described Receives: Drug: Netarsudil ophthalmic solution 0.02% |
| Artificial Tears | Placebo comparator | Not described Receives: Drug: Artificial tears |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean diurnal intraocular pressure (IOP)
Between-group difference in change in mean diurnal IOP
Measured: 42 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start27 Jun 2025
- Primary completion31 Jul 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Primary Open Angle Glaucoma or Ocular HypertensionStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- East Coast Institute for Research
- Sponsor type
- Research network
- Collaborators
- Alcon, a Novartis Company, Florida Eye Specialists
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06865144
- Sponsor's protocol ID
- ECIR-Alcon-02
- Status last verified
- Jun 2026
- First submitted
- 4 Mar 2025
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only IPD used in the results publication
Publications
Stuart, Annie. "Drug Update: Vyzulta and Rhopressa." Glaucoma Clinical Update, 31 Aug. 2018.
Zaman F, Gieser SC, Schwartz GF, Swan C, Williams JM. A multicenter, open-label study of netarsudil for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension in a real-world setting. Curr Med Res Opin. 2021 Jun;37(6):1011-1020. doi: 10.1080/03007995.2021.1901222. Epub 2021 Mar 27.
PubMed 33733980Gazzard G, Konstantakopoulou E, Garway-Heath D, Garg A, Vickerstaff V, Hunter R, Ambler G, Bunce C, Wormald R, Nathwani N, Barton K, Rubin G, Buszewicz M; LiGHT Trial Study Group. Selective laser trabeculoplasty versus eye drops for first-line treatment of ocular hypertension and glaucoma (LiGHT): a multicentre randomised controlled trial. Lancet. 2019 Apr 13;393(10180):1505-1516. doi: 10.1016/S0140-6736(18)32213-X. Epub 2019 Mar 9.
PubMed 30862377Kass MA, Heuer DK, Higginbotham EJ, Johnson CA, Keltner JL, Miller JP, Parrish RK 2nd, Wilson MR, Gordon MO. The Ocular Hypertension Treatment Study: a randomized trial determines that topical ocular hypotensive medication delays or prevents the onset of primary open-angle glaucoma. Arch Ophthalmol. 2002 Jun;120(6):701-13; discussion 829-30. doi: 10.1001/archopht.120.6.701.
PubMed 12049574Allison K, Patel D, Alabi O. Epidemiology of Glaucoma: The Past, Present, and Predictions for the Future. Cureus. 2020 Nov 24;12(11):e11686. doi: 10.7759/cureus.11686.
PubMed 33391921
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Double- Masked Study to Evaluate the Effect of Rhopressa Versus Placebo on Intraocular Pressure (IOP) in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension Post-Selective Laser Trabeculoplasty (SLT)
- ClinicalTrials.gov ID
- NCT06865144
- Acronym / sponsor ID
- ECIR-Alcon-02
- Keywords
- primary open angle glaucoma, ocular hypertension, SLT, POAG, Selective Laser Trabeculoplasty, Rhopressa, netarsudil
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- East Coast Institute for ResearchResearch network
- Collaborators
- Alcon, a Novartis Company, Florida Eye Specialists
- Study start
- 27 Jun 2025 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 7 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.
The purpose of this study is to collect data about how Rhopressa affects IOP in patients who have had an SLT procedure in both eyes.
Detailed description
This is a prospective, randomized, double-masked, placebo controlled (artificial tears), single center study. The study population will include seventy (n=70) subjects with POAG or ocular hypertension who have undergone SLT and may benefit from additional IOP reduction. If individuals are a candidate for treatment with Rhopressa (netarsudil) 0.02% ophthalmic solution post-SLT, they can potentially be included in the trial. The study duration per subject is expected to be 6 weeks (or up to 12 weeks if washout is required for previous IOP lowering treatment) with three scheduled study visits.
While both Rhopressa and 360 degrees SLT primarily target the trabecular meshwork, potential synergistic effects of the two therapies on conventional aqueous outflow are not completely understood. This study will determine whether initiation of Rhopressa post-360 degrees SLT provides greater IOP reduction than 360 degrees SLT alone. This information will aid healthcare providers in selecting the best approach to management of IOP in patients who have recently undergone 360 degrees SLT and may benefit from additional IOP reduction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rhopressa | Experimental | Drug: Netarsudil ophthalmic solution 0.02% |
| Artificial Tears | Placebo comparator | Drug: Artificial tears |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years
- Documented diagnosis of bilateral POAG or ocular hypertension as determined by the investigator based on medical record review.
- At Screening (V1), the subject completed SLT in both the eyes within the last 90 days.
- Mean diurnal IOP of 16 to 28 mmHg at Randomization (V2 )
- At Randomization (V2), in the opinion of the investigator, subject may benefit from additional IOP reduction in the study eye and is a candidate for treatment with Rhopressa
Key exclusion criteria (13 listed)
- History of more than one treatment with SLT in either eye
- Unable or unwilling to discontinue current IOP-lowering medication(s), if applicable
- Prior or current treatment with a rho kinase inhibitor
- Prior microinvasive glaucoma surgery (MIGS)
- Advanced stage of glaucoma, as determined by the investigator based on medical record review
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 ophthalmic solution 0.02%Also: RhopressaApply one drop in each eye every evening | Drug | Rhopressa |
| Artificial tearsApply one drop in each eye every evening | Drug | Artificial Tears |
Primary outcome
Mean diurnal intraocular pressure (IOP)
Time frame: 42 Days
Between-group difference in change in mean diurnal IOP
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 10 Jun 2026.
- BackgroundStuart, Annie. "Drug Update: Vyzulta and Rhopressa." Glaucoma Clinical Update, 31 Aug. 2018.
- Background: PubMed 33733980Zaman F, Gieser SC, Schwartz GF, Swan C, Williams JM. A multicenter, open-label study of netarsudil for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension in a real-world setting. Curr Med Res Opin. 2021 Jun;37(6):1011-1020. doi: 10.1080/03007995.2021.1901222. Epub 2021 Mar 27.
- Background: PubMed 30862377Gazzard G, Konstantakopoulou E, Garway-Heath D, Garg A, Vickerstaff V, Hunter R, Ambler G, Bunce C, Wormald R, Nathwani N, Barton K, Rubin G, Buszewicz M; LiGHT Trial Study Group. Selective laser trabeculoplasty versus eye drops for first-line treatment of ocular hypertension and glaucoma (LiGHT): a multicentre randomised controlled trial. Lancet. 2019 Apr 13;393(10180):1505-1516. doi: 10.1016/S0140-6736(18)32213-X. Epub 2019 Mar 9.
- Background: PubMed 12049574Kass MA, Heuer DK, Higginbotham EJ, Johnson CA, Keltner JL, Miller JP, Parrish RK 2nd, Wilson MR, Gordon MO. The Ocular Hypertension Treatment Study: a randomized trial determines that topical ocular hypotensive medication delays or prevents the onset of primary open-angle glaucoma. Arch Ophthalmol. 2002 Jun;120(6):701-13; discussion 829-30. doi: 10.1001/archopht.120.6.701.
- Background: PubMed 33391921Allison K, Patel D, Alabi O. Epidemiology of Glaucoma: The Past, Present, and Predictions for the Future. Cureus. 2020 Nov 24;12(11):e11686. doi: 10.7759/cureus.11686.
- Individual participant dataSharing planned: Yes. Only IPD used in the results publication
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 ophthalmic solution 0.02% and Artificial tears in people with Primary Open Angle Glaucoma or Ocular Hypertension, run by East Coast Institute for Research 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 13 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: under way, not looking for participants, as of the sponsor's last update on 10 Jun 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. Some participants in this study may receive a placebo. 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?
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?
Mean diurnal intraocular pressure (IOP) (time frame: 42 Days). 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 NCT06865144, which also lists 5 linked publications.
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 10 Jun 2026.