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Double-masked Study of Netarsudil (AR-13324) Ophthalmic Solution in Subjects With Glaucoma or Ocular Hypertension

Primary Purpose

Open-angle Glaucoma, Ocular Hypertension

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
AR-13324 Ophthalmic Solution 0.02%
Timolol Maleate Ophthalmic Solution 0.5% BID
Placebo
Sponsored by
Aerie Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Open-angle Glaucoma

Eligibility Criteria

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

Inclusion Criteria:

  1. 18 years of age or older
  2. Diagnosis of open angle glaucoma or ocular hypertension in both eyes
  3. Post-washout intraocular pressure >20mmHg and <30mmHg in 1 or both eyes at 2 qualification visits
  4. Corrected visual acuity equivalent to 20/200
  5. Able to give informed consent and follow study instructions

Exclusion Criteria:

  1. Clinically significant ocular disease
  2. Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure or narrow angles
  3. Unmedicated intraocular pressure ≥30mmHg
  4. Use of more than 2 ocular hypotensive medications within 30 days of screening
  5. Known hypersensitivity to any component of the formulation
  6. Previous glaucoma surgery or refractive surgery
  7. Ocular trauma within 6 months prior to screening
  8. Any ocular surgery or non-refractive laser treatment within 3 months prior to screening
  9. Recent or current ocular infection or inflammation in either eye
  10. Used ocular medication in either eye of any kind within 30 days of screening
  11. Mean central corneal thickness >620µm at screening
  12. Any abnormality preventing reliable applanation tonometry of either eye
  13. Clinically significant abnormalities in lab tests at screening
  14. Known hypersensitivity or contraindication to beta-adrenoceptor antagonists
  15. Clinically significant systemic disease
  16. Participation in any investigational study within 60 days prior to screening
  17. Used any systemic medication that could have a substantial effect in intraocular pressure within 30 days prior to screening
  18. Women who are pregnant, nursing, planning a pregnancy or not using a medically acceptable form of birth control

Sites / Locations

  • Aerie Pharmaceuticals

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

AR-13324 Ophthalmic Solution 0.02% & placebo

Timolol Maleate Ophthalmic Solution 0.5% BID

Arm Description

1 drop AR-13324 in the evening (PM) & 1 drop placebo in the morning (AM) in both eyes (OU)

1 drop twice daily (BID) in the morning (AM) & evening (PM) in both eyes (OU)

Outcomes

Primary Outcome Measures

IOP (Intraocular Pressure)
The primary efficacy outcome is mean IOP

Secondary Outcome Measures

Extent of Exposure
Exposure to study medication in days for all treatment groups

Full Information

First Posted
September 16, 2015
Last Updated
March 9, 2018
Sponsor
Aerie Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02558374
Brief Title
Double-masked Study of Netarsudil (AR-13324) Ophthalmic Solution in Subjects With Glaucoma or Ocular Hypertension
Official Title
A Double-masked, Randomized, Multi-center, Active-controlled, Parallel Group, 6-month Study With a 3-month Interim Analysis Assessing the Ocular Hypotensive Efficacy and Safety of AR-13324 Ophthalmic Solution, 0.02% QD Compared to Timolol Maleate Ophthalmic Solution, 0.5% BID in Patients With Elevated Intraocular Pressure
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
To evaluate ocular hypotensive efficacy and safety of Netarsudil (AR-13324) Ophthalmic Solution compared to Timolol Maleate Ophthalmic Solution.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
708 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AR-13324 Ophthalmic Solution 0.02% & placebo
Arm Type
Experimental
Arm Description
1 drop AR-13324 in the evening (PM) & 1 drop placebo in the morning (AM) in both eyes (OU)
Arm Title
Timolol Maleate Ophthalmic Solution 0.5% BID
Arm Type
Active Comparator
Arm Description
1 drop twice daily (BID) in the morning (AM) & evening (PM) in both eyes (OU)
Intervention Type
Drug
Intervention Name(s)
AR-13324 Ophthalmic Solution 0.02%
Other Intervention Name(s)
Netarsudil
Intervention Description
1 drop once daily (QD), PM, OU
Intervention Type
Drug
Intervention Name(s)
Timolol Maleate Ophthalmic Solution 0.5% BID
Intervention Description
1 drop BID, AM/PM, OU
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
1 drop QD, AM, OU
Primary Outcome Measure Information:
Title
IOP (Intraocular Pressure)
Description
The primary efficacy outcome is mean IOP
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Extent of Exposure
Description
Exposure to study medication in days for all treatment groups
Time Frame
6 months

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 Diagnosis of open angle glaucoma or ocular hypertension in both eyes Post-washout intraocular pressure >20mmHg and <30mmHg in 1 or both eyes at 2 qualification visits Corrected visual acuity equivalent to 20/200 Able to give informed consent and follow study instructions Exclusion Criteria: Clinically significant ocular disease Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure or narrow angles Unmedicated intraocular pressure ≥30mmHg Use of more than 2 ocular hypotensive medications within 30 days of screening Known hypersensitivity to any component of the formulation Previous glaucoma surgery or refractive surgery Ocular trauma within 6 months prior to screening Any ocular surgery or non-refractive laser treatment within 3 months prior to screening Recent or current ocular infection or inflammation in either eye Used ocular medication in either eye of any kind within 30 days of screening Mean central corneal thickness >620µm at screening Any abnormality preventing reliable applanation tonometry of either eye Clinically significant abnormalities in lab tests at screening Known hypersensitivity or contraindication to beta-adrenoceptor antagonists Clinically significant systemic disease Participation in any investigational study within 60 days prior to screening Used any systemic medication that could have a substantial effect in intraocular pressure within 30 days prior to screening Women who are pregnant, nursing, planning a pregnancy or not using a medically acceptable form of birth control
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theresa Heah, MD
Organizational Affiliation
Aerie Pharmaceuticals, Inc
Official's Role
Study Director
Facility Information:
Facility Name
Aerie Pharmaceuticals
City
Bedminster
State/Province
New Jersey
ZIP/Postal Code
07921
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Double-masked Study of Netarsudil (AR-13324) Ophthalmic Solution in Subjects With Glaucoma or Ocular Hypertension

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