Nocturnal/Diurnal Intraocular Pressure-Lowering Effect of Netarsudil Ophthalmic Solution

March 19, 2018 updated by: Aerie Pharmaceuticals

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Bedminster, New Jersey, United States, 07921
        • Nancy Ramirez

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 18 years of age or older.
  2. Ocular hypertension or open-angle glaucoma in both eyes.
  3. Unmedicated intraocular pressure > 17 mmHg in one or both eyes and < 30 mmHg in both eyes.
  4. Corrected visual acuity in each eye equivalent to 20/200 or better.
  5. Able and willing to give signed informed consent and follow study instructions.

Exclusion Criteria:

  1. Glaucoma with pseudoexfoliation or pigment dispersion component, history of angle closure, narrow angles.
  2. Intraocular pressure ≥ 30 mmHg.
  3. Use of ocular medications within 30 days.
  4. Known hypersensitivity to any component of the test formulations or to medications used routinely during a clinical eye examination.
  5. Previous eye surgery (other than cataract).
  6. Ocular trauma within 6 months.
  7. Clinically significant ocular disease that might interfere with the study.
  8. Central corneal thickness greater than 620 µm.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Netarsudil Ophthalmic Solution 0.02%
1 drop in each eye (OU) daily
Drug: Netarsudil ophthalmic solution 0.02%
Once daily in both eyes (OU) in the evening (PM) for 7 days
Other Names:
  • AR-13324
Placebo Comparator: Netarsudil Ophthalmic Solution Vehicle
1 drop in each eye (OU) daily
Other: Netarsudil Ophthalmic Solution Vehicle
Once daily in both eyes (OU) in the evening (PM) for 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Assessed over 24 hours at 9 pm, midnight, 3 am and 6 am on days 1/2 and 8/9

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time Frame: 7 days (day 1/2 to day 8/9)
7 days (day 1/2 to day 8/9)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aerie Pharmaceuticals

Investigators

  • Study Director: Theresa Heah, MD, Aerie Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

August 15, 2016

First Submitted That Met QC Criteria

August 17, 2016

First Posted (Estimate)

August 22, 2016

Study Record Updates

Last Update Posted (Actual)

April 17, 2018

Last Update Submitted That Met QC Criteria

March 19, 2018

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AR-13324-CS204

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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