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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

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ClinicalTrials.gov Identifier: NCT03844945
Recruitment Status : Recruiting
First Posted : February 19, 2019
Last Update Posted : May 14, 2019
Sponsor:
Information provided by (Responsible Party):
Aerie Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Open Angle Glaucoma Ocular Hypertension Drug: Netarsudil Ophthalmic Solution 0.01% Drug: Netarsudil Ophthalmic Solution 0.02% Drug: Netarsudil Ophthalmic Solution 0.04% Other: Netarsudil Ophthalmic Solution Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 208 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : March 19, 2019
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019


Arm Intervention/treatment
Experimental: Netarsudil Ophthalmic Solution 0.01%
1 drop daily into each eye in the evening for 28 days
Drug: Netarsudil Ophthalmic Solution 0.01%
Topical sterile ophthalmic solution

Experimental: Netarsudil Ophthalmic Solution 0.02%
1 drop daily into each eye in the evening for 28 days
Drug: Netarsudil Ophthalmic Solution 0.02%
Topical sterile ophthalmic solution
Other Name: Rhopressa®

Experimental: Netarsudil Ophthalmic Solution 0.04%
1 drop daily into each eye in the evening for 28 days
Drug: Netarsudil Ophthalmic Solution 0.04%
Topical sterile ophthalmic solution

Placebo Comparator: Netarsudil Ophthalmic Solution Placebo
1 drop daily into each eye in the evening for 28 days
Other: Netarsudil Ophthalmic Solution Placebo
Topical sterile ophthalmic solution




Primary Outcome Measures :
  1. Intraocular Pressure (IOP) [ Time Frame: 29 Days ]
    Mean diurnal IOP within a treatment by Goldman Applanation Tonometry



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03844945


Contacts
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Contact: Nancy Ramirez 8885945111 nramirez@aeriepharma.com

Locations
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Japan
Nomura Eye Clinic Recruiting
Ichinomiya-shi, Aichi, Japan
Shisui ophthalmology clinic Recruiting
Shisui, Chiba, Japan
Nakamori Eye Clinic Recruiting
Kitakyushu-shi, Fukuoka, Japan
Southern TOHOKU Eye Clinic Recruiting
Koriyama-shi, Fukushima, Japan
Kusatsu Eye Clinic Recruiting
Hiroshima-shi, Hiroshima, Japan
Kanamori Eye Clinic Recruiting
Akashi-shi, Hyogo, Japan
Sameshima Eye Clinic Recruiting
Kagoshima-shi, Kagoshima, Japan
Asahigaoka Ophthalmology Recruiting
Sendai-shi, Miyagi, Japan
Sugao Eye Clinic Recruiting
Osaka-shi, Osaka, Japan
Yubikai Kawaguchi Aozora Eye Clinic Recruiting
Kawaguchi-shi, Saitama-Ken, Japan
Hangai Eye Institute Recruiting
Saitama-shi, Saitama, Japan
Omiya Hamada Eye Clinic West Entrance Branch Recruiting
Saitama-shi, Saitama, Japan
Omiya Hamada Eye Clinic Recruiting
Saitama-shi, Saitama, Japan
Shibuya Ophthalmology Clinic Recruiting
Saitama-shi, Saitama, Japan
Yoshimura Eye & Internal Medical Clinic Recruiting
Mishima, Shiizuoka, Japan
Medical Corporation Muramatsu Clinic Muramatsu Eye Clinic Recruiting
Susono, Shizuoka-ken, Japan
Ueda Eye Clinic Recruiting
Arakawa-ku, Tokyo, Japan
Ochanomizu Inoue Eye Clinic Recruiting
Chiyoda-ku, Tokyo, Japan
Kiyosawa Eye Clinic Recruiting
Koto-Ku, Tokyo, Japan
Tamagawa Eye Clinic Recruiting
Ota-ku, Tokyo, Japan
Seijo Clinic Recruiting
Setagaya-Ku, Tokyo, Japan
Dogenzaka Kato Eye Clinic Recruiting
Shibuya-ku, Tokyo, Japan
Wakabadai Eye Clinic Recruiting
Shibuya-ku, Tokyo, Japan
Hashida Eye Clinic Recruiting
Shinagawa-Ku, Tokyo, Japan
Watanabe Eye Clinic Recruiting
Shinagawa-Ku, Tokyo, Japan
Sponsors and Collaborators
Aerie Pharmaceuticals
Investigators
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Study Director: Theresa Heah, MD, MBA Aerie Pharmaceuticals, Inc.

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Responsible Party: Aerie Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03844945     History of Changes
Other Study ID Numbers: AR-13324-CS208
First Posted: February 19, 2019    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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

Keywords provided by Aerie Pharmaceuticals:
Glaucoma
Ocular Hypertension
Open-Angle Glaucoma

Additional relevant MeSH terms:
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Hypertension
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions