Primary Open Angle GlaucomaPhase 4NCT07048886
Rocklatan Adds Pressure Reduction After MIGS (Minimally Invasive Glaucoma Surgery)
A Phase 4 study testing Rocklatan (netarsudil 0.02% and latanoprost 0.005%) and Systane in people with Primary Open Angle Glaucoma, run by Center for Sight Las Vegas at 1 site in United States.
Trial summary
The primary objective of this study is to determine if the addition of Rocklatan post-Hydrus will provide additional intraocular pressure lowering. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Primary Open Angle Glaucoma
- What is being tested?
- Rocklatan (netarsudil 0.02% and latanoprost 0.005%) and Systane
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2025to 31 Dec 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 40 years and older
- Subjects who have mild to moderate Open Angle Glaucoma (OAG)
- Subjects who have undergone uncomplicated cataract surgery and Hydrus microstent implantation > 3 months prior to screening and within the last 2 years
- Post-Hydrus subjects on 0-2 ocular hypotensive medication classes who can safely washout (if on ocular hypotensive medications)
- Unmedicated or washed out IOP range between 16-26 mmHg
Who cannot join
- History of intraocular surgery except for uneventful refractive surgery or uncomplicated cataract surgery and hydrus microstent implantation
- Prior Selective Laser Trabeculoplasty (SLT) within 18 months of surgery
- Secondary glaucoma excluding pseudoexfoliation and pigmentary dispersion syndrome
- Severe Open Angle Glaucoma
- Narrow angles, other angle abnormalities or angle closure glaucoma
- Allergy or intolerance to Rocklatan
Show all 12Show fewer
- History of corneal edema, or corneal disease or dystrophy
- Current or history of intra-ocular infection or inflammation
- History of retinal diseases that could affect diagnostic testing
- Anticipated use of intra-ocular or topical steroids not associated with the study protocol
- Pregnant, breastfeeding or planning to become pregnant during the study
- Any condition in the opinion in the investigator that would potentially confound the results of 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.
Clinical Research Coordinator contact
United States1 site
Center for Sight
Las Vegas, Nevada, 89145
Clinical Research Manager, 702-724-2005, jodi.kennedy@c4slv.com
Clinical Research Coordinator
About this study
The primary objective of this study is to determine if the addition of Rocklatan post-Hydrus will provide additional intraocular pressure lowering.
Read the detailed description
The study is a prospective single-practice with multiple locations, single-surgeon, parallel double arm study in subjects with open angle glaucoma (OAG), who were implanted with Hydrus microstent combined with cataract surgery to be randomized to receive Rocklatan vs. Comparator (artificial tears). Unmedicated MDIOP (mean diurnal intraocular pressure) measurements will be assessed at baseline (after Hydrus, prior to study medication) and at 1-month post-initiation of Study Drop.
- Conditions
- Primary Open Angle Glaucoma
- Being tested
- Rocklatan (netarsudil 0.02% and latanoprost 0.005%), Systane
- Keywords
- Primary Open Angle Glaucoma, Rocklatan
- 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.
Rocklatan (netarsudil 0.02% and latanoprost 0.005%)Drug
Additional intraocular eye pressure lowering post-Hydrus
SystaneDrug
Placebo Comparator (artificial tears)
| Study group | Role | What they receive |
|---|---|---|
| Placebo Comparator Systane Artificial Tears | Placebo comparator | Comparator arm is Systane artificial tears Receives: Drug: Systane |
| FDA Approved Rocklatan (netarsudil 0.02% and latanoprost 0.005%) | Active comparator | FDA approved Rocklatan (netarsudil 0.02% and latanoprost 0.005%) is a fixed dose combination of a Rho kinase inhibitor and a prostaglandin analogue indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Receives: Drug: Rocklatan (netarsudil 0.02% and latanoprost 0.005%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean diurnal intraocular pressure change from baseline
After Hydrus prior to study initiation drop
Measured: After 28 days up to 35 days post initiation of Rocklatan vs placebo comparator
Secondary outcomes (1)
Diurnal Intraocular pressure change from baseline and difference between intraocular pressure at each time point
Goldmann Applanation Tonometry
Measured: After Hydrus prior to study drop and after 28 days up to 35 days post initiation of study drop for all time points 8am, 10am, 4pm (± 1 hour) between groups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start15 Jul 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center for Sight Las Vegas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Medical Director, Medical Doctor, Principal investigator, Center For Sight
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07048886
- Sponsor's protocol ID
- CFS-RAPRAM-101
- Other IDs
- 96015755
- Status last verified
- Jun 2025
- First submitted
- 15 Jun 2025
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We do not plan to share individual participant data due to concerns about participant privacy and confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rocklatan Adds Pressure Reduction After MIGS (Minimally Invasive Glaucoma Surgery)
- ClinicalTrials.gov ID
- NCT07048886
- Acronym / sponsor ID
- CFS-RAPRAM-101
- Conditions
- Primary Open Angle Glaucoma
- Keywords
- Primary Open Angle Glaucoma, Rocklatan
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Center for Sight Las VegasUniversity, hospital or other
- Study start
- 15 Jul 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 Jul 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 primary objective of this study is to determine if the addition of Rocklatan post-Hydrus will provide additional intraocular pressure lowering.
Detailed description
The study is a prospective single-practice with multiple locations, single-surgeon, parallel double arm study in subjects with open angle glaucoma (OAG), who were implanted with Hydrus microstent combined with cataract surgery to be randomized to receive Rocklatan vs. Comparator (artificial tears). Unmedicated MDIOP (mean diurnal intraocular pressure) measurements will be assessed at baseline (after Hydrus, prior to study medication) and at 1-month post-initiation of Study Drop.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Comparator Systane Artificial Tears | Placebo comparator | Drug: SystaneComparator arm is Systane artificial tears |
| FDA Approved Rocklatan (netarsudil 0.02% and latanoprost 0.005%) | Active comparator | Drug: Rocklatan (netarsudil 0.02% and latanoprost 0.005%)FDA approved Rocklatan (netarsudil 0.02% and latanoprost 0.005%) is a fixed dose combination of a Rho kinase inhibitor and a prostaglandin analogue indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 40 years and older
- Subjects who have mild to moderate Open Angle Glaucoma (OAG)
- Subjects who have undergone uncomplicated cataract surgery and Hydrus microstent implantation > 3 months prior to screening and within the last 2 years
- Post-Hydrus subjects on 0-2 ocular hypotensive medication classes who can safely washout (if on ocular hypotensive medications)
- Unmedicated or washed out IOP range between 16-26 mmHg
Key exclusion criteria (12 listed)
- History of intraocular surgery except for uneventful refractive surgery or uncomplicated cataract surgery and hydrus microstent implantation
- Prior Selective Laser Trabeculoplasty (SLT) within 18 months of surgery
- Secondary glaucoma excluding pseudoexfoliation and pigmentary dispersion syndrome
- Severe Open Angle Glaucoma
- Narrow angles, other angle abnormalities or angle closure 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 |
|---|---|---|
| Rocklatan (netarsudil 0.02% and latanoprost 0.005%)Additional intraocular eye pressure lowering post-Hydrus | Drug | FDA Approved Rocklatan (netarsudil 0.02% and latanoprost 0.005%) |
| SystanePlacebo Comparator (artificial tears) | Drug | Placebo Comparator Systane Artificial Tears |
Primary outcome
Mean diurnal intraocular pressure change from baseline
Time frame: After 28 days up to 35 days post initiation of Rocklatan vs placebo comparator
After Hydrus prior to study initiation drop
1 secondary outcome
Diurnal Intraocular pressure change from baseline and difference between intraocular pressure at each time point
Time frame: After Hydrus prior to study drop and after 28 days up to 35 days post initiation of study drop for all time points 8am, 10am, 4pm (± 1 hour) between groups
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 3 Jul 2025.
- Individual participant dataSharing planned: Undecided. We do not plan to share individual participant data due to concerns about participant privacy and confidentiality.
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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.
Clinical Research Coordinator contact
Medical Director, Medical Doctor principal investigator
Center For Sight
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 Rocklatan (netarsudil 0.02% and latanoprost 0.005%) and Systane in people with Primary Open Angle Glaucoma, run by Center for Sight Las Vegas 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 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: opening soon, as of the sponsor's last update on 3 Jul 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. 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?
Contact Clinical Research Manager (702-724-2005, jodi.kennedy@c4slv.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean diurnal intraocular pressure change from baseline (time frame: After 28 days up to 35 days post initiation of Rocklatan vs placebo comparator). 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 3 Jul 2025.