Primary Open Angle Glaucoma or Ocular HypertensionPhase 2NCT03233308
Study of Netarsudil Ophthalmic Solution in Subjects With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)
A Phase 2 study testing Netarsudil Ophthalmic Solution 0.02% in people with Primary Open Angle Glaucoma or Ocular Hypertension, run by Aerie Pharmaceuticals at 2 sites in United States.
Trial summary
To evaluate the effect on trabecular outflow facility of Netarsudil ophthalmic solution 0.02% compared to placebo 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?
- Netarsudil Ophthalmic Solution 0.02%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Oct 2017to 19 Apr 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 of age or older
- Diagnosis of open primary angle glaucoma(POAG) or ocular hypertension (OHT) in both eyes
- Unmedicated intraocular pressure (IOP) >20 mmHg and < 30 mmHg in both eyes at first qualification visit
- Best corrected visual acuity (BCVA) equivalent to 20/200 Snellen or better
- Able to give informed consent and follow study instructions
Who cannot join
- Ophthalmic:
- Clinically significant ocular disease
- Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure glaucoma, or narrow angles
- Intraocular pressure ≥30 mmHg in either eye
- A difference in IOP between eyes >4mmHg at qualification visit
- Use of more than two ocular hypotensive medications within 30 days of screening
Show all 21Show fewer
- Known hypersensitivity to any component of the formulation
- Previous glaucoma surgery or refractive surgery
- Keratorefractive surgery in either eye
- Report of ocular injury in either eye within the six months prior to screening or ocular or non-refractive surgery 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
- Mean central corneal thickness greater than 620 μm in either eye
- Any abnormality preventing reliable applanation tonometry of either eye
- Lack of suitable episcleral vein prior to performing Episcleral Venus Pressure (EVP) measurement (applicable to 1 site only)
- Systemic:
- Clinically significant abnormalities within 6 weeks prior to screening
- Clinically significant systemic disease
- Participation in any investigational study within 60 days prior to screening
- Use of systemic medication that could have an effect on intraocular pressure within 30 days prior to screening
- Women of childbearing potential who were pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Duke Eye Center
Durham, North Carolina, 27710
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: A Double-Masked, Randomized, Placebo-Controlled Study of Trabecular Outflow Facility Following Treatment With Netarsudil Ophthalmic Solution 0.02% (AR-13324) in Subjects With Elevated Intraocular Pressure
To evaluate the effect on trabecular outflow facility of Netarsudil ophthalmic solution 0.02% compared to placebo
Read the detailed description
Trabecular outflow facility is a measure of aqueous humor dynamics; effect of netarsudil on this parameter as well as on intraocular pressure and episcleral venous pressure was evaluated in this study. Netarsudil treatment was given in one eye and placebo given in contralateral eye for 7 consecutive days.
- Being tested
- Netarsudil Ophthalmic Solution 0.02%, Placebo Comparator
- Keywords
- Aqueous Humor Dynamics, Trabecular Outflow, Netarsudil
- 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
1 drop daily (QD), in the morning (AM) Netarsudil Ophthalmic Solution 0.02% administered to one eye and Placebo comparator to the contralateral eye
Placebo ComparatorOther
1 drop daily (QD), in the morning (AM) of Placebo comparator administered to one eye and Netarsudil Ophthalmic Solution 0.02% to the contralateral eye
| Study group | Role | What they receive |
|---|---|---|
| Netarsudil Ophthalmic Solution 0.02% | Experimental | Netarsudil Ophthalmic Solution 0.02% was administered in one eye and Placebo comparator in contralateral eye Receives: Drug: Netarsudil Ophthalmic Solution 0.02%; Other: Placebo Comparator |
| Placebo Comparator | Placebo comparator | Placebo comparator administered in one eye and Netarsudil Ophthalmic Solution 0.02% in contralateral eye Receives: Drug: Netarsudil Ophthalmic Solution 0.02%; Other: Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline in the Mean Diurnal Trabecular Outflow Facility
Mean diurnal change from baseline in trabecular (tonographic) outflow facility.
Measured: Study treatment was administered for 7 days, and outcome measures collected on Day 8
Mean Percent Change From Baseline in the Mean Diurnal Trabecular Outflow Facility.
Mean diurnal change from baseline in trabecular (tonographic) outflow facility.
Measured: Study treatment was administered for 7 days, and outcome measures collected on Day 8
Secondary outcomes (2)
Mean Change From Baseline in Episcleral Venous Pressure (EVP) and in Intraocular Pressure (IOP)
Mean diurnal change from baseline in mean diurnal IOP measured using a Pneumatonometer and mean diurnal EVP using a custom-modified slit-lamp mounted venomanometer. (EVP conducted at a single site in only 9 participants)
Measured: Study treatment was administered for 7 days, and outcome measures collected on Day 8
Mean Percent Change From Baseline in Episcleral Venous Pressure (EVP) and in Intraocular Pressure (IOP)
Mean diurnal change from baseline in mean diurnal IOP measured using a Pneumatonometer and mean diurnal EVP using a custom-modified slit-lamp mounted venomanometer. (EVP conducted at a single site in only 9 participants)
Measured: Study treatment was administered for 7 days, and outcome measures collected on Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2017
- Study start20 Oct 2017
- Primary completion19 Apr 2018
- Study completion19 Apr 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
- Model description
- Paired comparison study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 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
- NCT03233308
- Sponsor's protocol ID
- AR-13324-CS206
- Status last verified
- Jul 2019
- First submitted
- 12 Jul 2017
- Last updated
- 6 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Masked, Randomized, Placebo-Controlled Study of Trabecular Outflow Facility Following Treatment With Netarsudil Ophthalmic Solution 0.02% (AR-13324) in Subjects With Elevated Intraocular Pressure
- ClinicalTrials.gov ID
- NCT03233308
- Acronym / sponsor ID
- AR-13324-CS206
- Keywords
- Aqueous Humor Dynamics, Trabecular Outflow, Netarsudil
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Aerie PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 20 Oct 2017 (actual)
- Primary completion
- 19 Apr 2018 (actual)
- Study completion
- 19 Apr 2018 (actual)
- First posted
- 28 Jul 2017 (actual)
- Results
- Posted 11 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the effect on trabecular outflow facility of Netarsudil ophthalmic solution 0.02% compared to placebo
Detailed description
Trabecular outflow facility is a measure of aqueous humor dynamics; effect of netarsudil on this parameter as well as on intraocular pressure and episcleral venous pressure was evaluated in this study. Netarsudil treatment was given in one eye and placebo given in contralateral eye for 7 consecutive days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Paired comparison study
| Arm | Type | Receives |
|---|---|---|
| Netarsudil Ophthalmic Solution 0.02% | Experimental | Drug: Netarsudil Ophthalmic Solution 0.02%, Other: Placebo ComparatorNetarsudil Ophthalmic Solution 0.02% was administered in one eye and Placebo comparator in contralateral eye |
| Placebo Comparator | Placebo comparator | Drug: Netarsudil Ophthalmic Solution 0.02%, Other: Placebo ComparatorPlacebo comparator administered in one eye and Netarsudil Ophthalmic Solution 0.02% in contralateral eye |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Must be 18 years of age or older
- Diagnosis of open primary angle glaucoma(POAG) or ocular hypertension (OHT) in both eyes
- Unmedicated intraocular pressure (IOP) >20 mmHg and < 30 mmHg in both eyes at first qualification visit
- Best corrected visual acuity (BCVA) equivalent to 20/200 Snellen or better
- Able to give informed consent and follow study instructions
Key exclusion criteria (21 listed)
- Clinically significant ocular disease
- Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure glaucoma, or narrow angles
- Intraocular pressure ≥30 mmHg in either eye
- A difference in IOP between eyes >4mmHg at qualification visit
- Use of more than two ocular hypotensive medications within 30 days of screening
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%1 drop daily (QD), in the morning (AM) Netarsudil Ophthalmic Solution 0.02% administered to one eye and Placebo comparator to the contralateral eye | Drug | Netarsudil Ophthalmic Solution 0.02%, Placebo Comparator |
| Placebo Comparator1 drop daily (QD), in the morning (AM) of Placebo comparator administered to one eye and Netarsudil Ophthalmic Solution 0.02% to the contralateral eye | Other | Netarsudil Ophthalmic Solution 0.02%, Placebo Comparator |
Primary outcome
Mean Change From Baseline in the Mean Diurnal Trabecular Outflow Facility
Time frame: Study treatment was administered for 7 days, and outcome measures collected on Day 8
Mean diurnal change from baseline in trabecular (tonographic) outflow facility.
Mean Percent Change From Baseline in the Mean Diurnal Trabecular Outflow Facility.
Time frame: Study treatment was administered for 7 days, and outcome measures collected on Day 8
Mean diurnal change from baseline in trabecular (tonographic) outflow facility.
2 secondary outcomes
Mean Change From Baseline in Episcleral Venous Pressure (EVP) and in Intraocular Pressure (IOP)
Time frame: Study treatment was administered for 7 days, and outcome measures collected on Day 8
Mean Percent Change From Baseline in Episcleral Venous Pressure (EVP) and in Intraocular Pressure (IOP)
Time frame: Study treatment was administered for 7 days, and outcome measures collected on Day 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Nancy Ramirez-Davis study director
Aerie Pharmaceuticals
2 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 0.02% in people with Primary Open Angle Glaucoma or Ocular Hypertension, run by Aerie Pharmaceuticals at 2 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 5 inclusion and 21 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 6 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 11 Jun 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 Change From Baseline in the Mean Diurnal Trabecular Outflow Facility (time frame: Study treatment was administered for 7 days, and outcome measures collected on Day 8). The study lists 2 primary outcomes in all. 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 6 Aug 2019.