Primary Open Angle GlaucomaPhase 3NCT04620135
Efficacy and Safety Study of Netarsudil 0.02% Ophthalmic Solution Compared to Ripasudil Hydrochloride Hydrate 0.4% Ophthalmic Solution in Japanese Subjects With Primary Open Angle Glaucoma or Ocular Hypertension
A Phase 3 study testing Netarsudil ophthalmic solution 0.02% and Ripasudil hydrochloride hydrate ophthalmic solution 0.4% in people with Primary Open Angle Glaucoma and Ocular Hypertension, run by Aerie Pharmaceuticals at 1 site in Japan.
Trial summary
A Phase 3 Study Comparing the Efficacy and Safety of Netarsudil Ophthalmic Solution 0.02% QD to Ripasudil Hydrochloride Hydrate Ophthalmic Solution 0.4% BID, for Treatment of Primary Open-Angle Glaucoma or Ocular Hypertension Over A 4-Week Period. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Primary Open Angle Glaucoma, Ocular Hypertension
- What is being tested?
- Netarsudil ophthalmic solution 0.02% and Ripasudil hydrochloride hydrate ophthalmic solution 0.4%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 245 participants
- Where
- 1 siteJapan
- Study dates
- 30 Nov 2020to 30 Jul 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 20 years of age or older
- Diagnosis of POAG or OHT in both eyes (POAG in one eye and OHT in the fellow eye was acceptable)
- Medicated intraocular pressure (IOP) ≥ 14 mmHg in at least one eye and < 30 mmHg in both eyes at screening visit
- For POAG eyes, unmedicated (post washout) IOP ≥ 15 mmHg and < 35 mmHg in the study eye at 2 qualification visits (09:00 hours), 2-7 days apart. At second qualification visit IOP ≥ 15 mmHg and < 35 mmHg at 11:00 and 16:00 hour (in the same eye).
- For OHT eyes, unmedicated (post washout) IOP ≥ 22 mmHg and < 35 mmHg in the study eye at 2 qualification visits (09:00 hours), 2-7 days apart. At second qualification visit IOP ≥ 22 mmHg and < 35 mmHg at 11:00 and 16:00 hours (in the same eye)
- Best-corrected visual acuity (BCVA) +0.7 log MAR or better (20/100 Snellen or better or 0.20 or better in decimal unit) in each eye
- Willingness and ability to give signed informed consent and follow study instructions
Who cannot join
- Clinically significant ocular disease
- Retinal diseases that may progress during the study period
- Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure glaucoma, or narrow angles
- Previous glaucoma intraocular surgery
- Refractive surgery in either eye
- Ocular hyperemia score of moderate (+2) or severe (+3) at Qualification Visit #2
Show all 17Show fewer
- Ocular trauma
- Ocular infection or inflammation
- Any corneal disease that may confound assessment
- Evidence of corneal deposits or cornea verticillata
- Known hypersensitivity to any component of netarsudil ophthalmic solution 0.02%, ripasudil hydrochloride hydrate ophthalmic solution 0.4%, or to topical anesthetic.
- Mean central corneal thickness >620 um
- Any abnormality preventing reliable Goldmann applanation tonometry of either eye (e.g. keratoconus)
- Cannot demonstrate proper delivery of the eye drop
- Clinically significant systemic disease
- Participation in any investigational study within 30 days prior to screening
- Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-masked, Randomized, Multi-center, Parallel-group, 4-week Study Evaluating the Efficacy and Safety of Once Daily Netarsudil Ophthalmic Solution 0.02% Compared to Twice Daily Ripasudil Hydrochloride Hydrate Ophthalmic Solution 0.4% in Japanese Subjects With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)
A Phase 3 Study Comparing the Efficacy and Safety of Netarsudil Ophthalmic Solution 0.02% QD to Ripasudil Hydrochloride Hydrate Ophthalmic Solution 0.4% BID, for Treatment of Primary Open-Angle Glaucoma or Ocular Hypertension Over A 4-Week Period.
- Conditions
- Primary Open Angle Glaucoma, Ocular Hypertension
- Being tested
- Netarsudil ophthalmic solution 0.02%, Ripasudil hydrochloride hydrate ophthalmic solution 0.4%
- Keywords
- Glaucoma, Primary Open-Angle Glaucoma, Ocular Hypertension
- 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 Vehicle: Netarsudil ophthalmic solution
Topical sterile ophthalmic solution Other Name: Rhopressa®
Ripasudil hydrochloride hydrate ophthalmic solution 0.4%Drug
Other Name: Glanatec®
| Study group | Role | What they receive |
|---|---|---|
| Netarsudil ophthalmic solution 0.02% and netarsudil ophthalmic solution vehicle | Experimental | 1 drop netarsudil 0.02% in the evening and 1 drop netarsudil vehicle in the morning in each eye. Receives: Drug: Netarsudil ophthalmic solution 0.02% |
| Ripasudil hydrochloride hydrate ophthalmic solution 0.4% | Active comparator | 1 drop ripasudil twice daily in the morning and evening in each eye. Receives: Drug: Ripasudil hydrochloride hydrate ophthalmic solution 0.4% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular Pressure (IOP)
Comparison of both groups mean diurnal IOP at Week 4 (Day 29). IOP will be measured by Goldmann applanation tonometry and reported in millimeters mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Mean diurnal IOP was calculated as the average of 3 IOP values across 09:00, 11:00 and 16:00 time points.
Measured: 29 Days
Secondary outcomes (2)
IOP at Weeks 1 and 2
Mean diurnal IOP as measured in mmHg at each post-treatment visit.
Measured: Day 8, Day 15
Mean Change IOP From Baseline at Days 8, 15, 29
Mean change from baseline in mean diurnal IOP as measured in mmHg at each post-treatment visit.
Measured: Baseline (Day 1), Days 8, 15, 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start30 Nov 2020
- Primary completion9 Jul 2021
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 245 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aerie Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joella Kittrell, Study director, Aerie Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04620135
- Sponsor's protocol ID
- AR-13324-CS305
- Status last verified
- Feb 2023
- First submitted
- 26 Oct 2020
- Last updated
- 27 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Araie M, Sugiyama K, Aso K, Kanemoto K, Iwata R, Hollander DA, Senchyna M, Kopczynski CC. Phase 3 Clinical Trial Comparing the Safety and Efficacy of Netarsudil to Ripasudil in Patients with Primary Open-Angle Glaucoma or Ocular Hypertension: Japan Rho Kinase Elevated Intraocular Pressure Treatment Trial (J-ROCKET). Adv Ther. 2023 Oct;40(10):4639-4656. doi: 10.1007/s12325-023-02550-w. Epub 2023 Aug 21.
PubMed 37603205
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-masked, Randomized, Multi-center, Parallel-group, 4-week Study Evaluating the Efficacy and Safety of Once Daily Netarsudil Ophthalmic Solution 0.02% Compared to Twice Daily Ripasudil Hydrochloride Hydrate Ophthalmic Solution 0.4% in Japanese Subjects With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)
- ClinicalTrials.gov ID
- NCT04620135
- Acronym / sponsor ID
- AR-13324-CS305
- Conditions
- Primary Open Angle Glaucoma, Ocular Hypertension
- Keywords
- Glaucoma, Primary Open-Angle Glaucoma, Ocular Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- Aerie PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2020 (actual)
- Primary completion
- 9 Jul 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 6 Nov 2020 (actual)
- Results
- Posted 27 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 3 Study Comparing the Efficacy and Safety of Netarsudil Ophthalmic Solution 0.02% QD to Ripasudil Hydrochloride Hydrate Ophthalmic Solution 0.4% BID, for Treatment of Primary Open-Angle Glaucoma or Ocular Hypertension Over A 4-Week Period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Netarsudil ophthalmic solution 0.02% and netarsudil ophthalmic solution vehicle | Experimental | Drug: Netarsudil ophthalmic solution 0.02%1 drop netarsudil 0.02% in the evening and 1 drop netarsudil vehicle in the morning in each eye. |
| Ripasudil hydrochloride hydrate ophthalmic solution 0.4% | Active comparator | Drug: Ripasudil hydrochloride hydrate ophthalmic solution 0.4%1 drop ripasudil twice daily in the morning and evening in each eye. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 20 years of age or older
- Diagnosis of POAG or OHT in both eyes (POAG in one eye and OHT in the fellow eye was acceptable)
- Medicated intraocular pressure (IOP) ≥ 14 mmHg in at least one eye and < 30 mmHg in both eyes at screening visit
- For POAG eyes, unmedicated (post washout) IOP ≥ 15 mmHg and < 35 mmHg in the study eye at 2 qualification visits (09:00 hours), 2-7 days apart. At second qualification visit IOP ≥ 15 mmHg and < 35 mmHg at 11:00 and 16:00 hour (in the same eye).
- For OHT eyes, unmedicated (post washout) IOP ≥ 22 mmHg and < 35 mmHg in the study eye at 2 qualification visits (09:00 hours), 2-7 days apart. At second qualification visit IOP ≥ 22 mmHg and < 35 mmHg at 11:00 and 16:00 hours (in the same eye)
Key exclusion criteria (17 listed)
- Clinically significant ocular disease
- Retinal diseases that may progress during the study period
- Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure glaucoma, or narrow angles
- Previous glaucoma intraocular surgery
- Refractive surgery in either eye
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: Vehicle: Netarsudil ophthalmic solutionTopical sterile ophthalmic solution Other Name: Rhopressa® | Drug | Netarsudil ophthalmic solution 0.02% and netarsudil ophthalmic solution vehicle |
| Ripasudil hydrochloride hydrate ophthalmic solution 0.4%Other Name: Glanatec® | Drug | Ripasudil hydrochloride hydrate ophthalmic solution 0.4% |
Primary outcome
Intraocular Pressure (IOP)
Time frame: 29 Days
Comparison of both groups mean diurnal IOP at Week 4 (Day 29). IOP will be measured by Goldmann applanation tonometry and reported in millimeters mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Mean diurnal IOP was calculated as the average of 3 IOP values across 09:00, 11:00 and 16:00 time points.
2 secondary outcomes
IOP at Weeks 1 and 2
Time frame: Day 8, Day 15
Mean Change IOP From Baseline at Days 8, 15, 29
Time frame: Baseline (Day 1), Days 8, 15, 29
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37603205Araie M, Sugiyama K, Aso K, Kanemoto K, Iwata R, Hollander DA, Senchyna M, Kopczynski CC. Phase 3 Clinical Trial Comparing the Safety and Efficacy of Netarsudil to Ripasudil in Patients with Primary Open-Angle Glaucoma or Ocular Hypertension: Japan Rho Kinase Elevated Intraocular Pressure Treatment Trial (J-ROCKET). Adv Ther. 2023 Oct;40(10):4639-4656. doi: 10.1007/s12325-023-02550-w. Epub 2023 Aug 21.
- 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. This study is not recruiting at the moment.
Joella Kittrell study director
Aerie Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Netarsudil ophthalmic solution 0.02% and Ripasudil hydrochloride hydrate ophthalmic solution 0.4% in people with Primary Open Angle Glaucoma and Ocular Hypertension, run by Aerie Pharmaceuticals at 1 site in Japan.
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 17 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: finished, as of the sponsor's last update on 27 Feb 2023. 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 Japan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Intraocular Pressure (IOP) (time frame: 29 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 NCT04620135, which also lists 1 linked publication.
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 27 Feb 2023.