NCT02874846

Brief Summary

To evaluate effect of Netarsudil Ophthalmic Solution 0.02% on Nocturnal and Diurnal Intraocular Pressure.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2016

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 22, 2016

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

April 17, 2018

Completed
Last Updated

April 17, 2018

Status Verified

October 1, 2016

Enrollment Period

2 months

First QC Date

August 15, 2016

Results QC Date

January 23, 2018

Last Update Submit

March 19, 2018

Conditions

Ocular HypertensionOpen Angle Glaucoma

Outcome Measures

Primary Outcomes (1)

  • 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

    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

    7 days (day 1/2 to day 8/9)

Study Arms (2)

Netarsudil Ophthalmic Solution 0.02%

EXPERIMENTAL

1 drop in each eye (OU) daily

Drug: Netarsudil ophthalmic solution 0.02%

Netarsudil Ophthalmic Solution Vehicle

PLACEBO COMPARATOR

1 drop in each eye (OU) daily

Other: Netarsudil Ophthalmic Solution Vehicle

Interventions

Netarsudil ophthalmic solution 0.02%DRUG

Once daily in both eyes (OU) in the evening (PM) for 7 days

Also known as: AR-13324
Netarsudil Ophthalmic Solution 0.02%
Netarsudil Ophthalmic Solution VehicleOTHER

Once daily in both eyes (OU) in the evening (PM) for 7 days

Netarsudil Ophthalmic Solution Vehicle

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nancy Ramirez

Bedminster, New Jersey, 07921, United States

Location

Related Publications (1)

  • 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.

    PMID: 33244711DERIVED

MeSH Terms

Conditions

Ocular HypertensionGlaucoma, Open-Angle

Interventions

netarsudil

Condition Hierarchy (Ancestors)

Eye DiseasesGlaucoma

Results Point of Contact

Title
Nancy Ramirez-Davis, Director of Clinical Project Management
Organization
Aerie Pharmaceuticals, Inc.
nramirez@aeriepharma.com
908-947-3543

Study Officials

  • Theresa Heah, MD

    Aerie Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2016

First Posted

August 22, 2016

Study Start

July 1, 2016

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

April 17, 2018

Results First Posted

April 17, 2018

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)