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

Primary Purpose

Ocular Hypertension, Open Angle Glaucoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Netarsudil ophthalmic solution 0.02%
Netarsudil Ophthalmic Solution Vehicle
Sponsored by
Aerie Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ocular Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Nancy Ramirez

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Netarsudil Ophthalmic Solution 0.02%

Netarsudil Ophthalmic Solution Vehicle

Arm Description

1 drop in each eye (OU) daily

1 drop in each eye (OU) daily

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of Participants With Adverse Events as a Measure of Safety and Tolerability

Full Information

First Posted
August 15, 2016
Last Updated
March 19, 2018
Sponsor
Aerie Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02874846
Brief Title
Nocturnal/Diurnal Intraocular Pressure-Lowering Effect of Netarsudil Ophthalmic Solution
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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
July 2016 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aerie Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ocular Hypertension, Open Angle Glaucoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Netarsudil Ophthalmic Solution 0.02%
Arm Type
Experimental
Arm Description
1 drop in each eye (OU) daily
Arm Title
Netarsudil Ophthalmic Solution Vehicle
Arm Type
Placebo Comparator
Arm Description
1 drop in each eye (OU) daily
Intervention Type
Drug
Intervention Name(s)
Netarsudil ophthalmic solution 0.02%
Other Intervention Name(s)
AR-13324
Intervention Description
Once daily in both eyes (OU) in the evening (PM) for 7 days
Intervention Type
Other
Intervention Name(s)
Netarsudil Ophthalmic Solution Vehicle
Intervention Description
Once daily in both eyes (OU) in the evening (PM) for 7 days
Primary Outcome Measure Information:
Title
Change in Intraocular Pressure (IOP) Over Nocturnal Time Period
Description
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
Time Frame
Assessed over 24 hours at 9 pm, midnight, 3 am and 6 am on days 1/2 and 8/9
Secondary Outcome Measure Information:
Title
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time Frame
7 days (day 1/2 to day 8/9)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theresa Heah, MD
Organizational Affiliation
Aerie Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Nancy Ramirez
City
Bedminster
State/Province
New Jersey
ZIP/Postal Code
07921
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33244711
Citation
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.
Results Reference
derived

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

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