Primary Open Angle Glaucoma or Ocular HypertensionPhase 2NCT03310580
Study of Netarsudil Ophthalmic Solution in Japanese/Japanese-American Subjects With Open-angle Glaucoma or Ocular Hypertension
A Phase 2 study testing AR-13324 Ophthalmic Solution 0.02% and AR-13324 Ophthalmic Solution 0.04% in people with Primary Open Angle Glaucoma or Ocular Hypertension, run by Aerie Pharmaceuticals at 40 sites in United States.
Trial summary
To test the safety and effectiveness of AR-13324 0.02% and 0.04% ophthalmic solution relative to placebo in Japanese/Japanese-American subjects with open-angle glaucoma or ocular hypertension in US. 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?
- AR-13324 Ophthalmic Solution 0.02% and AR-13324 Ophthalmic Solution 0.04%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 40 sitesUnited States
- Study dates
- 15 Nov 2017to 25 Oct 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be 18 years or older
- Be of Japanese ethnicity within the 2nd generation defined as (a) 1st generation born in Japan, immigrated to US and (b) 2nd generation - parents are 1st generation and patient was born in US as an American citizen
- Diagnosis of open-angle glaucoma or ocular hypertension in both eyes
- Medicated intraocular pressure >/= 15 mmHg and < 30 mmHg in both eyes at screening
- OAG eyes - unmedicated IOP >/= 15 mmHg and < 35 mmHg at 2 qualification visits at 08:00, 10:00 and 16:00
- OHT eyes - unmedicated IOP >/= 22 mmHg and < 35mmHg at 08:00, 10:00 and 16:00
- Best corrected visual acuity + 1.0 logMAR or better by ETDRS in each eye
- Able to give signed informed consent and follow instructions
Who cannot join
- Clinically significant ocular disease
- Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure glaucoma or narrow angles
- Intraocular pressure >/=35 mmHg in either eye
- Ocular hyperemia score of moderate (+2) at qualification visit #2
- Previous glaucoma intraocular surgery
- Refractive surgery in either eye
Show all 17Show fewer
- Ocular injury within 6 months prior to screening or ocular surgery or non-refractive laser treatment within 3 months prior to screening
- Recent or current ocular infection or inflammation in either eye
- Use of ocular medication in either eye of any kind within 30 days of screening and throughout the study
- Mean central corneal thickness > 620 µm in either eye
- Any abnormality preventing reliable applanation tonometry of either eye
- Known hypersensitivity to benzalkonium chloride or excipients of netarsudil ophthalmic solution
- Clinically significant abnormalities in screening lab tests
- Clinically significant systemic disease that might interfere with the study
- Participated in any investigational study within 30 days prior to screening
- Systemic medication that could have a substantial effect on IOP within 30 days prior to screening or anticipated during the study
- 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
40 sites in 1 country.
40 sites in 1 country
United States40 sites
University of Michigan
Ann Arbor, Michigan, 48105
Milton M. Hom, OD FAAO FACAAISc
Azusa, California, 91702
Havana Research Institute
Burbank, California, 91506
Arizona Eye Center
Chandler, Arizona, 85224
MCB Clinical Research Centers LLC
Colorado Springs, Colorado, 80910
Emerson Clinical Research Institute
Falls Church, Virginia, 22046
Global Research Management
Glendale, California, 91204
Jenkins Eye Care
Honolulu, Hawaii, 96814
Winward Eye Physicians and Eye Surgeons
Kailua, Hawaii, 96704
Island Eye Care, Inc.
Kailua, Hawaii, 96740
Lake Travis Eye and Laser Center
Lakeway, Texas, 78734
Emil A. Stein MD Ltd
Las Vegas, Nevada, 89119
AdvanceMed Clinical Research
Las Vegas, Nevada, 89123
Southern California Eye Physicians & Surgeons
Los Alamitos, California, 90270
East West Eye Institute
Los Angeles, California, 90013
USC Roski Eye Institute University of Souther California
Los Angeles, California, 90033
Global Research Foundation
Los Angeles, California, 90041
They Eye Care Institute
Louisville, Kentucky, 40206
Optimed Research
Marysville, Ohio, 43040
University Eye Specialists
Maryville, Tennessee, 37803
VRF Eye Speciality Group
Memphis, Tennessee, 38120
DCT - Shah Research LLC dba Discovery Clinical Trials
Mission, Texas, 78572
Clayton Eye Clinical Research, LLC
Morrow, Georgia, 30260
Glaucoma Consultants and Center for Eye Research, PA
Mt. Pleasant, South Carolina, 29464
New York Eye Infirmary of Mount Sinai
New York, New York, 10003
The Shimmyo Group
New York, New York, 10016
Manhattan Eye Ear and Throat Hospital
New York, New York, 10065
The Eye Research Foundation
Newport Beach, California, 92663
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Southern California Eye Physicians Surgeons
Pasadena, California, 91105
North Bay Eye Associates Inc.
Petaluma, California, 94954
Arizona Glaucoma Specialists
Phoenix, Arizona, 85050
Martel Eye
Rancho Cordova, California, 95670
Round Rock Eye Consultants
Round Rock, Texas, 78681
San Antonio Eye Center
San Antonio, Texas, 78215
R and R Eye Research LLC
San Antonio, Texas, 78229
University of California
San Diego, California, 92093
AdvanceMed Clinical Research
San Diego, California, 92122
Glaucoma Center of San Francisco
San Francisco, California, 94105
Samsum Clinic
Santa Barbara, California, 93110
About this study
Official title: A Prospective, Double-masked, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Assessing the Safety and Ocular Hypotensive Efficacy and Optimum Concentration to be Used Clinically of Netarsudil Ophthalmic Solution in Japanese/Japanese-American Subjects With Open-angle Glaucoma or Ocular Hypertension in the United States
To test the safety and effectiveness of AR-13324 0.02% and 0.04% ophthalmic solution relative to placebo in Japanese/Japanese-American subjects with open-angle glaucoma or ocular hypertension in US.
- Being tested
- AR-13324 Ophthalmic Solution 0.02%, AR-13324 Ophthalmic Solution 0.04%, AR-13324 Ophthalmic Solution Placebo
- 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.
AR-13324 Ophthalmic Solution 0.02%Drug
Administered to each eye, once daily (QD) in the evening (PM) for 28 days
AR-13324 Ophthalmic Solution 0.04%Drug
Administered to each eye, once daily (QD) in the evening (PM) for 28 days
AR-13324 Ophthalmic Solution PlaceboDrug
Administered to each eye, once daily (QD) in the evening (PM) for 28 days
| Study group | Role | What they receive |
|---|---|---|
| AR-13324 Ophthalmic Solution 0.02% | Experimental | Topical sterile ophthalmic solution; 1 drop daily to each eye for 28 days Receives: Drug: AR-13324 Ophthalmic Solution 0.02% |
| AR-13324 Ophthalmic Solution 0.04% | Experimental | Topical sterile ophthalmic solution; 1 drop daily to each eye for 28 days Receives: Drug: AR-13324 Ophthalmic Solution 0.04% |
| Placebo Comparator | Placebo comparator | Topical sterile ophthalmic solution; 1 drop daily to each eye for 28 days Receives: Drug: AR-13324 Ophthalmic Solution Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Diurnal IOP (Intraocular Pressure) (mmHg)
Mean diurnal intraocular pressure (IOP) at week 4, measured by Goldman Applanation Tonometry (GAT).
Measured: 28 Days
Secondary outcomes (1)
Extent of Exposure
Exposure to study medication in days for all treatment groups
Measured: 28 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2017
- Study start15 Nov 2017
- Primary completion25 Oct 2018
- Study completion25 Oct 2018
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aerie Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nancy Ramirez-Davis, Study director, Aerie Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03310580
- Sponsor's protocol ID
- AR-13324-CS205
- Status last verified
- Dec 2019
- First submitted
- 13 Oct 2017
- Last updated
- 23 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2019. 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 and Ocular Hypotensive Efficacy and Optimum Concentration to be Used Clinically of Netarsudil Ophthalmic Solution in Japanese/Japanese-American Subjects With Open-angle Glaucoma or Ocular Hypertension in the United States
- ClinicalTrials.gov ID
- NCT03310580
- Acronym / sponsor ID
- AR-13324-CS205
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Aerie PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 15 Nov 2017 (actual)
- Primary completion
- 25 Oct 2018 (actual)
- Study completion
- 25 Oct 2018 (actual)
- First posted
- 16 Oct 2017 (actual)
- Results
- Posted 15 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To test the safety and effectiveness of AR-13324 0.02% and 0.04% ophthalmic solution relative to placebo in Japanese/Japanese-American subjects with open-angle glaucoma or ocular hypertension in US.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AR-13324 Ophthalmic Solution 0.02% | Experimental | Drug: AR-13324 Ophthalmic Solution 0.02%Topical sterile ophthalmic solution; 1 drop daily to each eye for 28 days |
| AR-13324 Ophthalmic Solution 0.04% | Experimental | Drug: AR-13324 Ophthalmic Solution 0.04%Topical sterile ophthalmic solution; 1 drop daily to each eye for 28 days |
| Placebo Comparator | Placebo comparator | Drug: AR-13324 Ophthalmic Solution PlaceboTopical sterile ophthalmic solution; 1 drop daily to each eye for 28 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Must be 18 years or older
- Be of Japanese ethnicity within the 2nd generation defined as (a) 1st generation born in Japan, immigrated to US and (b) 2nd generation - parents are 1st generation and patient was born in US as an American citizen
- Diagnosis of open-angle glaucoma or ocular hypertension in both eyes
- Medicated intraocular pressure >/= 15 mmHg and < 30 mmHg in both eyes at screening
- OAG eyes - unmedicated IOP >/= 15 mmHg and < 35 mmHg at 2 qualification visits at 08:00, 10:00 and 16:00
Key exclusion criteria (17 listed)
- Clinically significant ocular disease
- Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure glaucoma or narrow angles
- Intraocular pressure >/=35 mmHg in either eye
- Ocular hyperemia score of moderate (+2) at qualification visit #2
- Previous glaucoma intraocular surgery
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 |
|---|---|---|
| AR-13324 Ophthalmic Solution 0.02%Administered to each eye, once daily (QD) in the evening (PM) for 28 days | Drug | AR-13324 Ophthalmic Solution 0.02% |
| AR-13324 Ophthalmic Solution 0.04%Administered to each eye, once daily (QD) in the evening (PM) for 28 days | Drug | AR-13324 Ophthalmic Solution 0.04% |
| AR-13324 Ophthalmic Solution PlaceboAdministered to each eye, once daily (QD) in the evening (PM) for 28 days | Drug | Placebo Comparator |
Primary outcome
Mean Diurnal IOP (Intraocular Pressure) (mmHg)
Time frame: 28 Days
Mean diurnal intraocular pressure (IOP) at week 4, measured by Goldman Applanation Tonometry (GAT).
1 secondary outcome
Extent of Exposure
Time frame: 28 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Nancy Ramirez-Davis study director
Aerie Pharmaceuticals
40 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 AR-13324 Ophthalmic Solution 0.02% and AR-13324 Ophthalmic Solution 0.04% in people with Primary Open Angle Glaucoma or Ocular Hypertension, run by Aerie Pharmaceuticals at 40 sites 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 8 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 23 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites 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 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 15 Nov 2019). 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?
Mean Diurnal IOP (Intraocular Pressure) (mmHg) (time frame: 28 Days). 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 23 Dec 2019.