Ocular HypertensionPhase 2NCT02874846
Nocturnal/Diurnal Intraocular Pressure-Lowering Effect of Netarsudil Ophthalmic Solution
A Phase 2 study testing Netarsudil ophthalmic solution 0.02% in people with Ocular Hypertension and Open Angle Glaucoma, run by Aerie Pharmaceuticals at 1 site in United States.
Trial summary
To evaluate effect of Netarsudil Ophthalmic Solution 0.02% on Nocturnal and Diurnal Intraocular Pressure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ocular Hypertension, Open Angle Glaucoma
- What is being tested?
- Netarsudil ophthalmic solution 0.02%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Sep 2016
- 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
- 18 years of age or older.
- Ocular hypertension or open-angle glaucoma in both eyes.
- Unmedicated intraocular pressure > 17 mmHg in one or both eyes and < 30 mmHg in both eyes.
- Corrected visual acuity in each eye equivalent to 20/200 or better.
- Able and willing to give signed informed consent and follow study instructions.
Who cannot join
- Glaucoma with pseudoexfoliation or pigment dispersion component, history of angle closure, narrow angles.
- Intraocular pressure ≥ 30 mmHg.
- Use of ocular medications within 30 days.
- Known hypersensitivity to any component of the test formulations or to medications used routinely during a clinical eye examination.
- Previous eye surgery (other than cataract).
- Ocular trauma within 6 months.
- Clinically significant ocular disease that might interfere with the study.
- Central corneal thickness greater than 620 µm.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-masked, Randomized, Placebo-controlled Study of the Nocturnal and Diurnal IOP-lowering Effect of Netarsudil Ophthalmic Solution 0.02% in Habitual Positions Over a 24-hour Period.
To evaluate effect of Netarsudil Ophthalmic Solution 0.02% on Nocturnal and Diurnal Intraocular Pressure.
- Conditions
- Ocular Hypertension, Open Angle Glaucoma
- Being tested
- Netarsudil ophthalmic solution 0.02%, Netarsudil Ophthalmic Solution Vehicle
- Medical subject headings
- Ocular Hypertension, Glaucoma, Open-Angle
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 AR-13324
Once daily in both eyes (OU) in the evening (PM) for 7 days
Netarsudil Ophthalmic Solution VehicleOther
Once daily in both eyes (OU) in the evening (PM) for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Netarsudil Ophthalmic Solution 0.02% | Experimental | 1 drop in each eye (OU) daily Receives: Drug: Netarsudil ophthalmic solution 0.02% |
| Netarsudil Ophthalmic Solution Vehicle | Placebo comparator | 1 drop in each eye (OU) daily Receives: Other: Netarsudil Ophthalmic Solution Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Intraocular Pressure (IOP) Over Nocturnal Time Period
The primary efficacy endpoint was the mean change from baseline in mean nocturnal IOP (defined as the mean of the 4 nocturnal time points: 21:00, 00:00, 03:00, and 06:00 hours) on Day 8/Day 9
Measured: Assessed over 24 hours at 9 pm, midnight, 3 am and 6 am on days 1/2 and 8/9
Secondary outcomes (1)
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Measured: 7 days (day 1/2 to day 8/9)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2016 (estimated)
- Study startJul 2016
- Primary completionSep 2016
- Study completionSep 2016
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 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aerie Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Theresa Heah, MD, Study director, Aerie Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02874846
- Sponsor's protocol ID
- AR-13324-CS204
- Status last verified
- Oct 2016
- First submitted
- 15 Aug 2016
- Last updated
- 17 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Peace JH, McKee HJ, Kopczynski CC. A Randomized, Phase 2 Study of 24-h Efficacy and Tolerability of Netarsudil in Ocular Hypertension and Open-Angle Glaucoma. Ophthalmol Ther. 2021 Mar;10(1):89-100. doi: 10.1007/s40123-020-00322-1. Epub 2020 Nov 26.
PubMed 33244711
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-masked, Randomized, Placebo-controlled Study of the Nocturnal and Diurnal IOP-lowering Effect of Netarsudil Ophthalmic Solution 0.02% in Habitual Positions Over a 24-hour Period.
- ClinicalTrials.gov ID
- NCT02874846
- Acronym / sponsor ID
- AR-13324-CS204
- Conditions
- Ocular Hypertension, Open Angle Glaucoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Aerie PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 22 Aug 2016 (estimated)
- Results
- Posted 17 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate effect of Netarsudil Ophthalmic Solution 0.02% on Nocturnal and Diurnal Intraocular Pressure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Netarsudil Ophthalmic Solution 0.02% | Experimental | Drug: Netarsudil ophthalmic solution 0.02%1 drop in each eye (OU) daily |
| Netarsudil Ophthalmic Solution Vehicle | Placebo comparator | Other: Netarsudil Ophthalmic Solution Vehicle1 drop in each eye (OU) daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age or older.
- Ocular hypertension or open-angle glaucoma in both eyes.
- Unmedicated intraocular pressure > 17 mmHg in one or both eyes and < 30 mmHg in both eyes.
- Corrected visual acuity in each eye equivalent to 20/200 or better.
- Able and willing to give signed informed consent and follow study instructions.
Key exclusion criteria (8 listed)
- Glaucoma with pseudoexfoliation or pigment dispersion component, history of angle closure, narrow angles.
- Intraocular pressure ≥ 30 mmHg.
- Use of ocular medications within 30 days.
- Known hypersensitivity to any component of the test formulations or to medications used routinely during a clinical eye examination.
- Previous eye surgery (other than cataract).
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: AR-13324Once daily in both eyes (OU) in the evening (PM) for 7 days | Drug | Netarsudil Ophthalmic Solution 0.02% |
| Netarsudil Ophthalmic Solution VehicleOnce daily in both eyes (OU) in the evening (PM) for 7 days | Other | Netarsudil Ophthalmic Solution Vehicle |
Primary outcome
Change in Intraocular Pressure (IOP) Over Nocturnal Time Period
Time frame: Assessed over 24 hours at 9 pm, midnight, 3 am and 6 am on days 1/2 and 8/9
The primary efficacy endpoint was the mean change from baseline in mean nocturnal IOP (defined as the mean of the 4 nocturnal time points: 21:00, 00:00, 03:00, and 06:00 hours) on Day 8/Day 9
1 secondary outcome
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time frame: 7 days (day 1/2 to day 8/9)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33244711Peace JH, McKee HJ, Kopczynski CC. A Randomized, Phase 2 Study of 24-h Efficacy and Tolerability of Netarsudil in Ocular Hypertension and Open-Angle Glaucoma. Ophthalmol Ther. 2021 Mar;10(1):89-100. doi: 10.1007/s40123-020-00322-1. Epub 2020 Nov 26.
- 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.
Theresa Heah, MD 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 2 study testing Netarsudil ophthalmic solution 0.02% in people with Ocular Hypertension and Open Angle Glaucoma, run by Aerie Pharmaceuticals at 1 site 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 8 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 17 Apr 2018. 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 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 17 Apr 2018). 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?
Change in Intraocular Pressure (IOP) Over Nocturnal Time Period (time frame: Assessed over 24 hours at 9 pm, midnight, 3 am and 6 am on days 1/2 and 8/9). 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 NCT02874846, 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 17 Apr 2018.