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Efficacy and Systemic Safety of Netarsudil 0.01%, 0.02%, 0.04% Relative to Placebo in Subjects With Open-angle Glaucoma or Ocular Hypertension in Japan

Primary Purpose

Open Angle Glaucoma, Ocular Hypertension

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Netarsudil Ophthalmic Solution 0.01%
Netarsudil Ophthalmic Solution 0.02%
Netarsudil Ophthalmic Solution 0.04%
Netarsudil Ophthalmic Solution 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 focused on measuring Glaucoma, Ocular Hypertension, Open-Angle Glaucoma

Eligibility Criteria

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

Inclusion Criteria:

  1. Must be 20 years of age or older
  2. Diagnosis of open-angle glaucoma (OAG) or ocular hypertension (OHT) in both eyes. (OAG in one eye and OHT in the fellow eye is acceptable)
  3. BCVA 0.1 or better in decimal unit using Landolt-C chart or its equivalent
  4. Able and willing to give signed informed consent and following study instructions

Exclusion Criteria:

  1. Clinically significant ocular diseases
  2. Pseudoexfoliation or pigment dispersion component glaucoma, history of narrow angle closure glaucoma or narrow angles
  3. Previous glaucoma intraocular surgery
  4. Refractive surgery in either eye
  5. Ocular trauma
  6. Ocular infection or inflammation
  7. Known hypersensitivity to benzalkonium chloride or excipient of netarsudil ophthalmic solution
  8. Cannot demonstrate proper delivery of the eye drop
  9. Clinically significant abnormalities in screen lab tests
  10. Clinically significant systemic disease
  11. Participation in any investigational study within 30 days of screening
  12. Women of child-bearing potential who are pregnant, nursing, planning a pregnancy or not using a medically acceptable form of birth control

Sites / Locations

  • Nomura Eye Clinic
  • Shisui ophthalmology clinic
  • Nakamori Eye Clinic
  • Southern TOHOKU Eye Clinic
  • Kusatsu Eye Clinic
  • Kanamori Eye Clinic
  • Sameshima Eye Clinic
  • Asahigaoka Ophthalmology
  • Sugao Eye Clinic
  • Yubikai Kawaguchi Aozora Eye Clinic
  • Hangai Eye Institute
  • Omiya Hamada Eye Clinic West Entrance Branch
  • Omiya Hamada Eye Clinic
  • Shibuya Ophthalmology Clinic
  • Yoshimura Eye & Internal Medical Clinic
  • Medical Corporation Muramatsu Clinic Muramatsu Eye Clinic
  • Ueda Eye Clinic
  • Ochanomizu Inoue Eye Clinic
  • Kiyosawa Eye Clinic
  • Tamagawa Eye Clinic
  • Seijo Clinic
  • Dogenzaka Kato Eye Clinic
  • Wakabadai Eye Clinic
  • Hashida Eye Clinic
  • Watanabe Eye Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Netarsudil Ophthalmic Solution 0.01%

Netarsudil Ophthalmic Solution 0.02%

Netarsudil Ophthalmic Solution 0.04%

Netarsudil Ophthalmic Solution Placebo

Arm Description

1 drop daily into each eye in the evening for 28 days

1 drop daily into each eye in the evening for 28 days

1 drop daily into each eye in the evening for 28 days

1 drop daily into each eye in the evening for 28 days

Outcomes

Primary Outcome Measures

Intraocular Pressure (IOP)
Mean diurnal IOP within a treatment by Goldman Applanation Tonometry

Secondary Outcome Measures

Full Information

First Posted
February 15, 2019
Last Updated
September 23, 2020
Sponsor
Aerie Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT03844945
Brief Title
Efficacy and Systemic Safety of Netarsudil 0.01%, 0.02%, 0.04% Relative to Placebo in Subjects With Open-angle Glaucoma or Ocular Hypertension in Japan
Official Title
A Prospective, Double-masked, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Assessing the Safety, Ocular Hypotensive Efficacy and Optimum Dose Concentration to be Used Clinically of Netarsudil Ophthalmic Solution in Subjects With Open-angle Glaucoma or Ocular Hypertension in Japan
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
March 19, 2019 (Actual)
Primary Completion Date
September 19, 2019 (Actual)
Study Completion Date
September 19, 2019 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
Test ocular hypotensive efficacy and systemic safety of netarsudil 0.01%, 0.02%, 0.04% relative to placebo in subjects with open-angle glaucoma or ocular hypertension in Japan

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
215 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Netarsudil Ophthalmic Solution 0.01%
Arm Type
Experimental
Arm Description
1 drop daily into each eye in the evening for 28 days
Arm Title
Netarsudil Ophthalmic Solution 0.02%
Arm Type
Experimental
Arm Description
1 drop daily into each eye in the evening for 28 days
Arm Title
Netarsudil Ophthalmic Solution 0.04%
Arm Type
Experimental
Arm Description
1 drop daily into each eye in the evening for 28 days
Arm Title
Netarsudil Ophthalmic Solution Placebo
Arm Type
Placebo Comparator
Arm Description
1 drop daily into each eye in the evening for 28 days
Intervention Type
Drug
Intervention Name(s)
Netarsudil Ophthalmic Solution 0.01%
Intervention Description
Topical sterile ophthalmic solution
Intervention Type
Drug
Intervention Name(s)
Netarsudil Ophthalmic Solution 0.02%
Other Intervention Name(s)
Rhopressa®
Intervention Description
Topical sterile ophthalmic solution
Intervention Type
Drug
Intervention Name(s)
Netarsudil Ophthalmic Solution 0.04%
Intervention Description
Topical sterile ophthalmic solution
Intervention Type
Other
Intervention Name(s)
Netarsudil Ophthalmic Solution Placebo
Intervention Description
Topical sterile ophthalmic solution
Primary Outcome Measure Information:
Title
Intraocular Pressure (IOP)
Description
Mean diurnal IOP within a treatment by Goldman Applanation Tonometry
Time Frame
29 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Must be 20 years of age or older Diagnosis of open-angle glaucoma (OAG) or ocular hypertension (OHT) in both eyes. (OAG in one eye and OHT in the fellow eye is acceptable) BCVA 0.1 or better in decimal unit using Landolt-C chart or its equivalent Able and willing to give signed informed consent and following study instructions Exclusion Criteria: Clinically significant ocular diseases Pseudoexfoliation or pigment dispersion component glaucoma, history of narrow angle closure glaucoma or narrow angles Previous glaucoma intraocular surgery Refractive surgery in either eye Ocular trauma Ocular infection or inflammation Known hypersensitivity to benzalkonium chloride or excipient of netarsudil ophthalmic solution Cannot demonstrate proper delivery of the eye drop Clinically significant abnormalities in screen lab tests Clinically significant systemic disease Participation in any investigational study within 30 days of screening Women of child-bearing potential 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
Kenji Aso, M.D., Ph.D.
Organizational Affiliation
Aerie Pharmaceuticals Ireland Ltd. (Japan Branch)
Official's Role
Study Director
Facility Information:
Facility Name
Nomura Eye Clinic
City
Ichinomiya-shi
State/Province
Aichi
Country
Japan
Facility Name
Shisui ophthalmology clinic
City
Shisui
State/Province
Chiba
Country
Japan
Facility Name
Nakamori Eye Clinic
City
Kitakyushu-shi
State/Province
Fukuoka
Country
Japan
Facility Name
Southern TOHOKU Eye Clinic
City
Koriyama-shi
State/Province
Fukushima
Country
Japan
Facility Name
Kusatsu Eye Clinic
City
Hiroshima-shi
State/Province
Hiroshima
Country
Japan
Facility Name
Kanamori Eye Clinic
City
Akashi-shi
State/Province
Hyogo
Country
Japan
Facility Name
Sameshima Eye Clinic
City
Kagoshima-shi
State/Province
Kagoshima
Country
Japan
Facility Name
Asahigaoka Ophthalmology
City
Sendai-shi
State/Province
Miyagi
Country
Japan
Facility Name
Sugao Eye Clinic
City
Osaka-shi
State/Province
Osaka
Country
Japan
Facility Name
Yubikai Kawaguchi Aozora Eye Clinic
City
Kawaguchi-shi
State/Province
Saitama-Ken
Country
Japan
Facility Name
Hangai Eye Institute
City
Saitama-shi
State/Province
Saitama
Country
Japan
Facility Name
Omiya Hamada Eye Clinic West Entrance Branch
City
Saitama-shi
State/Province
Saitama
Country
Japan
Facility Name
Omiya Hamada Eye Clinic
City
Saitama-shi
State/Province
Saitama
Country
Japan
Facility Name
Shibuya Ophthalmology Clinic
City
Saitama-shi
State/Province
Saitama
Country
Japan
Facility Name
Yoshimura Eye & Internal Medical Clinic
City
Mishima
State/Province
Shiizuoka
Country
Japan
Facility Name
Medical Corporation Muramatsu Clinic Muramatsu Eye Clinic
City
Susono
State/Province
Shizuoka-ken
Country
Japan
Facility Name
Ueda Eye Clinic
City
Arakawa-ku
State/Province
Tokyo
Country
Japan
Facility Name
Ochanomizu Inoue Eye Clinic
City
Chiyoda-ku
State/Province
Tokyo
Country
Japan
Facility Name
Kiyosawa Eye Clinic
City
Koto-Ku
State/Province
Tokyo
Country
Japan
Facility Name
Tamagawa Eye Clinic
City
Ota-ku
State/Province
Tokyo
Country
Japan
Facility Name
Seijo Clinic
City
Setagaya-Ku
State/Province
Tokyo
Country
Japan
Facility Name
Dogenzaka Kato Eye Clinic
City
Shibuya-ku
State/Province
Tokyo
Country
Japan
Facility Name
Wakabadai Eye Clinic
City
Shibuya-ku
State/Province
Tokyo
Country
Japan
Facility Name
Hashida Eye Clinic
City
Shinagawa-Ku
State/Province
Tokyo
Country
Japan
Facility Name
Watanabe Eye Clinic
City
Shinagawa-Ku
State/Province
Tokyo
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33629227
Citation
Araie M, Sugiyama K, Aso K, Kanemoto K, Kothapalli K, Kopczynski C, Senchyna M, Hollander DA. Phase 2 Randomized Clinical Study of Netarsudil Ophthalmic Solution in Japanese Patients with Primary Open-Angle Glaucoma or Ocular Hypertension. Adv Ther. 2021 Apr;38(4):1757-1775. doi: 10.1007/s12325-021-01634-9. Epub 2021 Feb 24.
Results Reference
derived

Learn more about this trial

Efficacy and Systemic Safety of Netarsudil 0.01%, 0.02%, 0.04% Relative to Placebo in Subjects With Open-angle Glaucoma or Ocular Hypertension in Japan

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