Glaucoma, Open-AnglePhase 4NCT03808688

Study of Rhopressa® for the Reduction of Elevated Intraocular Pressure in Patients With Glaucoma or Ocular Hypertension in a Real-world Setting

A Phase 4 study testing Netarsudil Ophthalmic Solution 0.02% in people with Glaucoma, Open-Angle and Ocular Hypertension, run by Aerie Pharmaceuticals at 22 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To evaluate the IOP lowering efficacy of netarsudil ophthalmic solution 0.02% when used as monotherapy or when used concomitantly with other IOP-lowering agents in subjects with elevated IOP due to open angle glaucoma or ocular hypertension in a real-world clinical setting. The study is an open-label design. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Glaucoma, Open-Angle, Ocular Hypertension
What is being tested?: Netarsudil Ophthalmic Solution 0.02%
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 261 participants
Where: 22 sitesUnited States
Study dates: 27 Dec 2018to 26 Jul 2019
Phase: Phase 4
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

Male or female subjects (aged 18 or older)
Subjects diagnosed with open-angle glaucoma or ocular hypertension, and determined by the treating physician to require additional intraocular pressure (IOP)-lowering treatment with netarsudil 0.02%.
Willingness to follow protocol requirements, including signed informed consent, routine follow-up schedule, completing questionnaires and completing laboratory tests

Who cannot join

Have any active ocular disease other than glaucoma or ocular hypertension that would interfere with study interpretation
Women of childbearing potential who are pregnant, nursing, or planning a pregnancy and not using a medically acceptable form of birth control. Male subjects with a female partner of childbearing potential must have had a prior vasectomy or agree to use an effective method of birth control during the treatment period and for 3 months after the subject has completed the study.
Known sensitivity or allergy to the study medication or components
Any systemic disease or clinical evidence of any condition which would make the subject, in the opinion of the investigator, unsuitable for the study or could potentially confound the study results
Concurrent participation or prior participation in any investigational drug or device study within the last 30 days prior to the Baseline Visit

Trial locations and contacts

22 sites in 1 country.

City, postcode or hospital

22 sites in 1 country

United States22 sites

Keystone Research
Austin, Texas, 78731
Glaucoma Consultants
Baltimore, Maryland, 21204
Scott & Christie and Associates, PC
Cranberry Township, Pennsylvania, 16066
Cataract & Glaucoma Center
El Paso, Texas, 79902
Houston Eye Associates
Houston, Texas, 77025
Valley Eye Professionals, LLC
Huntingdon Valley, Pennsylvania, 19006
Atlantis Eyecare
Huntington Beach, California, 92647
Carolina Cataract & Laser Center
Ladson, South Carolina, 29456
Harvard Eye Associates
Laguna Hills, California, 92653
Shettle Eye Research Inc
Largo, Florida, 33773
Gaddie Eye Centers, LLC
Louisville, Kentucky, 40241
Total Eye Care, PA
Memphis, Tennessee, 38119
VRF Eye Specialty Group
Memphis, Tennessee, 38120
Advancing Vision Research
Nashville, Tennessee, 37204
Stiles Eyecare Excellence and Glaucoma Institute, PA
Overland Park, Kansas, 66213
North Bay Eye Associates, Inc
Petaluma, California, 94954
The Eye Centers of Racine and Kenosha
Racine, Wisconsin, 53405
Coastal Research Associates, LLC
Roswell, Georgia, 30076
Center For Sight
Sarasota, Florida, 34238
Tekwani Vision Center
St Louis, Missouri, 63128
Mark J. Weiss, M.D., Inc.
Tulsa, Oklahoma, 74104
Wheaton Eye Clinic, Ltd
Wheaton, Illinois, 60187

Other trials in United States

About this study

Official title: A Multicenter, Open-label Study of Rhopressa® (Netarsudil Ophthalmic Solution) 0.02% for the Reduction of Elevated Intraocular Pressure in Patients With Glaucoma or Ocular Hypertension in a Real-world Setting

Conditions: Glaucoma, Open-Angle, Ocular Hypertension
Being tested: Netarsudil Ophthalmic Solution 0.02%
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
1 drop in each eye once daily in the evening

Study groups in NCT03808688
Study group	Role	What they receive
Netarsudil Ophthalmic Solution 0.02%	Other	Not described Receives: Drug: Netarsudil Ophthalmic Solution 0.02%

What is being measured

The primary outcome is the main question the study is designed to answer.

Intraocular Pressure (IOP)
Percent Change from Baseline IOP at Week 12, as measured by Goldmann applanation tonometry.
Prostaglandin analog (PGA). Fixed dose combination (FDC).
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Dec 201826 Jul 2019

First posted17 Jan 2019
Study start27 Dec 2018
Primary completion26 Jul 2019
Study completion26 Jul 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 Glaucoma, Open-AngleStudies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 261 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03808688
Sponsor's protocol ID: MA-RHO-18-002
Status last verified: Nov 2019
First submitted: 10 Jan 2019
Last updated: 29 Sep 2020
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

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 33733980

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
Open Angle Glaucoma (OAG), Glaucoma
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Primary Open Angle Glaucoma

All Glaucoma, Open-Angle trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Open-label Study of Rhopressa® (Netarsudil Ophthalmic Solution) 0.02% for the Reduction of Elevated Intraocular Pressure in Patients With Glaucoma or Ocular Hypertension in a Real-world Setting
ClinicalTrials.gov ID: NCT03808688
Acronym / sponsor ID: MA-RHO-18-002
Conditions: Glaucoma, Open-Angle, Ocular Hypertension
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 261 participants (actual)
Lead sponsor: Aerie PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 27 Dec 2018 (actual)
Primary completion: 26 Jul 2019 (actual)
Study completion: 26 Jul 2019 (actual)
First posted: 17 Jan 2019 (actual)
Results: Posted 29 Sep 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Netarsudil Ophthalmic Solution 0.02%	Other	Drug: Netarsudil Ophthalmic Solution 0.02%

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Male or female subjects (aged 18 or older)
Subjects diagnosed with open-angle glaucoma or ocular hypertension, and determined by the treating physician to require additional intraocular pressure (IOP)-lowering treatment with netarsudil 0.02%.
Willingness to follow protocol requirements, including signed informed consent, routine follow-up schedule, completing questionnaires and completing laboratory tests

Key exclusion criteria (5 listed)

Have any active ocular disease other than glaucoma or ocular hypertension that would interfere with study interpretation
Women of childbearing potential who are pregnant, nursing, or planning a pregnancy and not using a medically acceptable form of birth control. Male subjects with a female partner of childbearing potential must have had a prior vasectomy or agree to use an effective method of birth control during the treatment period and for 3 months after the subject has completed the study.
Known sensitivity or allergy to the study medication or components
Any systemic disease or clinical evidence of any condition which would make the subject, in the opinion of the investigator, unsuitable for the study or could potentially confound the study results
Concurrent participation or prior participation in any investigational drug or device study within the last 30 days prior to the Baseline Visit

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: Rhopressa1 drop in each eye once daily in the evening	Drug	Netarsudil Ophthalmic Solution 0.02%

Primary outcome

Intraocular Pressure (IOP)
Time frame: 12 weeks
Percent Change from Baseline IOP at Week 12, as measured by Goldmann applanation tonometry. Prostaglandin analog (PGA). Fixed dose combination (FDC).

Results and safety

Results posted to the registry on 29 Sep 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Netarsudil Ophthalmic Solution 0.02% Monotherapy	99	81
Netarsudil Ophthalmic Solution 0.02% Concomitant Therapy	161	138

Primary outcome: Intraocular Pressure (IOP)

Time frame: 12 weeks. Mean (Standard Deviation). Unit: percent change

Measure	Netarsudil Ophth Sol 0.02% Monotherapy - Tx Naïve At Baseline n = 24	Netarsudil Ophth Sol 0.02% Monotherapy - Replaced 1 Agent n = 61	Netarsudil Ophth Sol 0.02% Monotherapy - Replaced 2 Agents n = 6	Netarsudil Ophth Sol 0.02% Concomitant Therapy n = 151
Value	-16.9 (16.35)	-2.3 (16.23)	0.2 (8.81)	-17.0 (16.81)

Population analysed: Modified Intent-to-Treat (mITT) population included all subjects who received at least 1 dose of study medication and had at least 1 follow-up visit with a completed IOP measurement.

Adverse events

Time frame: Adverse event data was collected during the course of the 12-week treatment period.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Netarsudil Ophthalmic Solution 0.02% Monotherapy	2 of 99 (2%)	43 of 99 (43.4%)	0 of 99
Netarsudil Ophthalmic Solution 0.02% Concomitant Therapy	1 of 161 (0.6%)	58 of 161 (36%)	0 of 161

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: 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.
Individual participant dataSharing planned: No

Related trials for Glaucoma, Open-Angle

RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
Open Angle Glaucoma (OAG), Glaucoma
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Primary Open Angle Glaucoma

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.

David Hollander, MD, MBA study director

Aerie Pharmaceuticals, Inc.

22 sites 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% in people with Glaucoma, Open-Angle and Ocular Hypertension, run by Aerie Pharmaceuticals at 22 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 3 inclusion and 5 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 29 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 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. 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?

Yes. Results are posted in the registry (first posted 29 Sep 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: 12 weeks). 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 NCT03808688, 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 29 Sep 2020.