Open Angle GlaucomaPhase 2NCT03844945
Efficacy and Systemic Safety of Netarsudil 0.01%, 0.02%, 0.04% Relative to Placebo in Subjects With Open-angle Glaucoma or Ocular Hypertension in Japan
A Phase 2 study testing Netarsudil Ophthalmic Solution 0.01%, Netarsudil Ophthalmic Solution 0.02% and Netarsudil Ophthalmic Solution 0.04% in people with Open Angle Glaucoma and Ocular Hypertension, run by Aerie Pharmaceuticals at 25 sites in Japan.
Trial summary
Test ocular hypotensive efficacy and systemic safety of netarsudil 0.01%, 0.02%, 0.04% relative to placebo in subjects with open-angle glaucoma or ocular hypertension in Japan Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Open Angle Glaucoma, Ocular Hypertension
- What is being tested?
- Netarsudil Ophthalmic Solution 0.01%, Netarsudil Ophthalmic Solution 0.02% and Netarsudil Ophthalmic Solution 0.04%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 215 participants
- Where
- 25 sitesJapan
- Study dates
- 19 Mar 2019to 19 Sep 2019
- Phase
- Phase 2
- 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
- Must be 20 years of age or older
- Diagnosis of open-angle glaucoma (OAG) or ocular hypertension (OHT) in both eyes. (OAG in one eye and OHT in the fellow eye is acceptable)
- BCVA 0.1 or better in decimal unit using Landolt-C chart or its equivalent
- Able and willing to give signed informed consent and following study instructions
Who cannot join
- Clinically significant ocular diseases
- Pseudoexfoliation or pigment dispersion component glaucoma, history of narrow angle closure glaucoma or narrow angles
- Previous glaucoma intraocular surgery
- Refractive surgery in either eye
- Ocular trauma
- Ocular infection or inflammation
Show all 12Show fewer
- Known hypersensitivity to benzalkonium chloride or excipient of netarsudil ophthalmic solution
- Cannot demonstrate proper delivery of the eye drop
- Clinically significant abnormalities in screen lab tests
- Clinically significant systemic disease
- Participation in any investigational study within 30 days of screening
- Women of child-bearing potential who are pregnant, nursing, planning a pregnancy or not using a medically acceptable form of birth control
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
Japan25 sites
Kanamori Eye Clinic
Akashi-shi, Hyōgo
Ueda Eye Clinic
Arakawa-ku, Tokyo
Ochanomizu Inoue Eye Clinic
Chiyoda-ku, Tokyo
Kusatsu Eye Clinic
Hiroshima, Hiroshima
Nomura Eye Clinic
Ichinomiya-shi, Aichi-ken
Sameshima Eye Clinic
Kagoshima, Kagoshima-ken
Yubikai Kawaguchi Aozora Eye Clinic
Kawaguchi-shi, Saitama
Nakamori Eye Clinic
Kitakyushu-shi, Fukuoka
Southern TOHOKU Eye Clinic
Koriyama-shi, Fukushima
Kiyosawa Eye Clinic
Koto-Ku, Tokyo
Yoshimura Eye & Internal Medical Clinic
Mishima, Shiizuoka
Sugao Eye Clinic
Osaka, Osaka
Tamagawa Eye Clinic
Ōta-ku, Tokyo
Hangai Eye Institute
Saitama-shi, Saitama
Omiya Hamada Eye Clinic West Entrance Branch
Saitama-shi, Saitama
Omiya Hamada Eye Clinic
Saitama-shi, Saitama
Shibuya Ophthalmology Clinic
Saitama-shi, Saitama
Asahigaoka Ophthalmology
Sendai, Miyagi
Seijo Clinic
Setagaya-Ku, Tokyo
Dogenzaka Kato Eye Clinic
Shibuya-ku, Tokyo
Wakabadai Eye Clinic
Shibuya-ku, Tokyo
Hashida Eye Clinic
Shinagawa-Ku, Tokyo
Watanabe Eye Clinic
Shinagawa-Ku, Tokyo
Shisui ophthalmology clinic
Shisui, Chiba
Medical Corporation Muramatsu Clinic Muramatsu Eye Clinic
Susono, Shizuoka
About this study
Official title: A Prospective, Double-masked, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Assessing the Safety, Ocular Hypotensive Efficacy and Optimum Dose Concentration to be Used Clinically of Netarsudil Ophthalmic Solution in Subjects With Open-angle Glaucoma or Ocular Hypertension in Japan
Test ocular hypotensive efficacy and systemic safety of netarsudil 0.01%, 0.02%, 0.04% relative to placebo in subjects with open-angle glaucoma or ocular hypertension in Japan
- Conditions
- Open Angle Glaucoma, Ocular Hypertension
- Being tested
- Netarsudil Ophthalmic Solution 0.01%, Netarsudil Ophthalmic Solution 0.02%, Netarsudil Ophthalmic Solution 0.04%, Netarsudil Ophthalmic Solution Placebo
- Keywords
- Glaucoma, Ocular Hypertension, Open-Angle Glaucoma
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Netarsudil Ophthalmic Solution 0.01%Drug
Topical sterile ophthalmic solution
Netarsudil Ophthalmic Solution 0.02%Drug
Also called Rhopressa®
Topical sterile ophthalmic solution
Netarsudil Ophthalmic Solution 0.04%Drug
Topical sterile ophthalmic solution
Netarsudil Ophthalmic Solution PlaceboOther
Topical sterile ophthalmic solution
| Study group | Role | What they receive |
|---|---|---|
| Netarsudil Ophthalmic Solution 0.01% | Experimental | 1 drop daily into each eye in the evening for 28 days Receives: Drug: Netarsudil Ophthalmic Solution 0.01% |
| Netarsudil Ophthalmic Solution 0.02% | Experimental | 1 drop daily into each eye in the evening for 28 days Receives: Drug: Netarsudil Ophthalmic Solution 0.02% |
| Netarsudil Ophthalmic Solution 0.04% | Experimental | 1 drop daily into each eye in the evening for 28 days Receives: Drug: Netarsudil Ophthalmic Solution 0.04% |
| Netarsudil Ophthalmic Solution Placebo | Placebo comparator | 1 drop daily into each eye in the evening for 28 days Receives: Other: Netarsudil Ophthalmic Solution Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular Pressure (IOP)
Mean diurnal IOP within a treatment by Goldman Applanation Tonometry
Measured: 29 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2019
- Study start19 Mar 2019
- Primary completion19 Sep 2019
- Study completion19 Sep 2019
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 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aerie Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kenji Aso, M.D., Ph.D., Study director, Aerie Pharmaceuticals Ireland Ltd. (Japan Branch)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03844945
- Sponsor's protocol ID
- AR-13324-CS208
- Status last verified
- Sep 2020
- First submitted
- 15 Feb 2019
- Last updated
- 19 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Araie M, Sugiyama K, Aso K, Kanemoto K, Kothapalli K, Kopczynski C, Senchyna M, Hollander DA. Phase 2 Randomized Clinical Study of Netarsudil Ophthalmic Solution in Japanese Patients with Primary Open-Angle Glaucoma or Ocular Hypertension. Adv Ther. 2021 Apr;38(4):1757-1775. doi: 10.1007/s12325-021-01634-9. Epub 2021 Feb 24.
PubMed 33629227
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Double-masked, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Assessing the Safety, Ocular Hypotensive Efficacy and Optimum Dose Concentration to be Used Clinically of Netarsudil Ophthalmic Solution in Subjects With Open-angle Glaucoma or Ocular Hypertension in Japan
- ClinicalTrials.gov ID
- NCT03844945
- Acronym / sponsor ID
- AR-13324-CS208
- Conditions
- Open Angle Glaucoma, Ocular Hypertension
- Keywords
- Glaucoma, Ocular Hypertension, Open-Angle Glaucoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- Aerie PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 19 Mar 2019 (actual)
- Primary completion
- 19 Sep 2019 (actual)
- Study completion
- 19 Sep 2019 (actual)
- First posted
- 19 Feb 2019 (actual)
- Results
- Posted 19 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Test ocular hypotensive efficacy and systemic safety of netarsudil 0.01%, 0.02%, 0.04% relative to placebo in subjects with open-angle glaucoma or ocular hypertension in Japan
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Netarsudil Ophthalmic Solution 0.01% | Experimental | Drug: Netarsudil Ophthalmic Solution 0.01%1 drop daily into each eye in the evening for 28 days |
| Netarsudil Ophthalmic Solution 0.02% | Experimental | Drug: Netarsudil Ophthalmic Solution 0.02%1 drop daily into each eye in the evening for 28 days |
| Netarsudil Ophthalmic Solution 0.04% | Experimental | Drug: Netarsudil Ophthalmic Solution 0.04%1 drop daily into each eye in the evening for 28 days |
| Netarsudil Ophthalmic Solution Placebo | Placebo comparator | Other: Netarsudil Ophthalmic Solution Placebo1 drop daily into each eye in the evening for 28 days |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Must be 20 years of age or older
- Diagnosis of open-angle glaucoma (OAG) or ocular hypertension (OHT) in both eyes. (OAG in one eye and OHT in the fellow eye is acceptable)
- BCVA 0.1 or better in decimal unit using Landolt-C chart or its equivalent
- Able and willing to give signed informed consent and following study instructions
Key exclusion criteria (12 listed)
- Clinically significant ocular diseases
- Pseudoexfoliation or pigment dispersion component glaucoma, history of narrow angle closure glaucoma or narrow angles
- Previous glaucoma intraocular surgery
- Refractive surgery in either eye
- Ocular trauma
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 0.01%Topical sterile ophthalmic solution | Drug | Netarsudil Ophthalmic Solution 0.01% |
| Netarsudil Ophthalmic Solution 0.02%Also: Rhopressa®Topical sterile ophthalmic solution | Drug | Netarsudil Ophthalmic Solution 0.02% |
| Netarsudil Ophthalmic Solution 0.04%Topical sterile ophthalmic solution | Drug | Netarsudil Ophthalmic Solution 0.04% |
| Netarsudil Ophthalmic Solution PlaceboTopical sterile ophthalmic solution | Other | Netarsudil Ophthalmic Solution Placebo |
Primary outcome
Intraocular Pressure (IOP)
Time frame: 29 Days
Mean diurnal IOP within a treatment by Goldman Applanation Tonometry
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33629227Araie M, Sugiyama K, Aso K, Kanemoto K, Kothapalli K, Kopczynski C, Senchyna M, Hollander DA. Phase 2 Randomized Clinical Study of Netarsudil Ophthalmic Solution in Japanese Patients with Primary Open-Angle Glaucoma or Ocular Hypertension. Adv Ther. 2021 Apr;38(4):1757-1775. doi: 10.1007/s12325-021-01634-9. Epub 2021 Feb 24.
- 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. This study is not recruiting at the moment.
Kenji Aso, M.D., Ph.D. study director
Aerie Pharmaceuticals Ireland Ltd. (Japan Branch)
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Netarsudil Ophthalmic Solution 0.01%, Netarsudil Ophthalmic Solution 0.02% and Netarsudil Ophthalmic Solution 0.04% in people with Open Angle Glaucoma and Ocular Hypertension, run by Aerie Pharmaceuticals at 25 sites 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 4 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: finished, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 19 Oct 2020). 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 NCT03844945, 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 19 Oct 2020.