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A Comparative Confirmatory Study of STN1012600 in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension

Primary Purpose

Primary Open Angle Glaucoma, Ocular Hypertension

Status
Recruiting
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
STN1012600 ophthalmic solution 0.002%
Latanoprost ophthalmic solution 0.005%
Sponsored by
Santen Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Open Angle Glaucoma, Ocular Hypertension

Eligibility Criteria

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

Inclusion Criteria:

  • 18 years of age or older.
  • Diagnosis of POAG or OHT in both eyes, or one eye with POAG and the other with OHT.
  • Corrected Visual Acuity of +0.60 logMAR (Decimal visual acuity 0.3) or better in each eye.

Exclusion Criteria:

  • Presence of any active severe external ocular disease, inflammation, or infection of the eye and/or eyelids in either eye.
  • History of severe ocular trauma in either eye.
  • Any condition that prevents clear visualization of the fundus in either eye.
  • Known allergy, hypersensitivity or contraindications to any components of the study medications or other study related procedures/medications.
  • History of ocular surgery specifically intended to lower IOP in either eye.
  • History of keratorefractive surgery in either eye.
  • Females who are pregnant, nursing, or planning a pregnancy.
  • Subjects with known or suspected drug or alcohol abuse.
  • Participation in other investigational drugs or device clinical trials within 30 days prior to Screening.
  • Any decision by the Investigator to terminate a subject in screening or declare any subject ineligible for any sound medical reason.

Sites / Locations

  • Eyecare NagoyaRecruiting
  • Kitanagoya Eye ClinicRecruiting
  • Takahashi Eye ClinicRecruiting
  • Kawabata Eye ClinicRecruiting
  • Mitsuhashi Eye ClinicRecruiting
  • Shisui Ophthalmology ClinicRecruiting
  • Takeda Eye ClinicRecruiting
  • Kanamori Eye ClinicRecruiting
  • Dannoue Eye ClinicRecruiting
  • Hodogaya iina Eye ClinicRecruiting
  • Honda Eye ClinicRecruiting
  • Yokosuka Chuoh Eye ClinicRecruiting
  • Kengun Sakuragi Eye ClinicRecruiting
  • Hideyuki Eye ClinicRecruiting
  • Iwashita Eye ClinicRecruiting
  • Maeda Eye ClinicRecruiting
  • Nishi Eye HospitalRecruiting
  • OCROM ClinicRecruiting
  • Onoe Eye ClinicRecruiting
  • Sugasawa Eye ClinicRecruiting
  • Sugiura Eye ClinicRecruiting
  • Tahara Eye ClinicRecruiting
  • Tane Memorial Eye HospitalRecruiting
  • Kawaguchi Aozora Eye ClinicRecruiting
  • Omiya Hamada Eye Clinic West entrance BranchRecruiting
  • Omiya Hamada Eye ClinicRecruiting
  • Shibuya Ophthalmology ClinicRecruiting
  • Muramatsu Eye ClinicRecruiting
  • Nakamura Eye ClinicRecruiting
  • Ono Ophthalmic ClinicRecruiting
  • Saito Eye ClinicRecruiting
  • Yoshimura Eye & Internal Medical ClinicRecruiting
  • Dogenzaka Kato Eye ClinicRecruiting
  • Hashida Eye ClinicRecruiting
  • Kakinoki Eye ClinicRecruiting
  • Seijo ClinicRecruiting
  • Shimizu Eye ClinicRecruiting
  • Shirayama Eye ClinicRecruiting
  • Suitengu Fujita Ophthalmo ClinicRecruiting
  • Tamagawa Eye ClinicRecruiting
  • Tokiwadai Muranaka Eye ClinicRecruiting
  • Ueda Eye ClinicRecruiting
  • Watanabe Eye ClinicRecruiting
  • IMAI Eye ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

STN1012600 0.002%

Latanoprost 0.005%

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in mean diurnal intraocular pressure
Change from baseline in mean diurnal intraocular pressure at Week 4

Secondary Outcome Measures

Full Information

First Posted
August 9, 2022
Last Updated
February 8, 2023
Sponsor
Santen Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05495061
Brief Title
A Comparative Confirmatory Study of STN1012600 in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension
Official Title
A Phase III, Randomized, Observer-Masked, Active-Controlled, Parallel-Group, Multicenter Study Assessing the Efficacy and Safety of STN1012600 Ophthalmic Solution 0.002% Compared With Latanoprost 0.005% in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension (Angel-J1 Study)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 9, 2022 (Actual)
Primary Completion Date
May 31, 2023 (Anticipated)
Study Completion Date
May 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Santen Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To investigate whether the IOP lowering efficacy of STN1012600 ophthalmic solution 0.002% is non-inferior to that of latanoprost 0.005% in subjects with POAG or OHT after treatment for 4 weeks.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
STN1012600 0.002%
Arm Type
Experimental
Arm Title
Latanoprost 0.005%
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
STN1012600 ophthalmic solution 0.002%
Intervention Description
1 drop STN1012600 ophthalmic solution 0.002% once daily for 3 months
Intervention Type
Drug
Intervention Name(s)
Latanoprost ophthalmic solution 0.005%
Intervention Description
1 drop Latanoprost ophthalmic solution 0.005% once daily for 3 months
Primary Outcome Measure Information:
Title
Change from baseline in mean diurnal intraocular pressure
Description
Change from baseline in mean diurnal intraocular pressure at Week 4
Time Frame
4 weeks

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 POAG or OHT in both eyes, or one eye with POAG and the other with OHT. Corrected Visual Acuity of +0.60 logMAR (Decimal visual acuity 0.3) or better in each eye. Exclusion Criteria: Presence of any active severe external ocular disease, inflammation, or infection of the eye and/or eyelids in either eye. History of severe ocular trauma in either eye. Any condition that prevents clear visualization of the fundus in either eye. Known allergy, hypersensitivity or contraindications to any components of the study medications or other study related procedures/medications. History of ocular surgery specifically intended to lower IOP in either eye. History of keratorefractive surgery in either eye. Females who are pregnant, nursing, or planning a pregnancy. Subjects with known or suspected drug or alcohol abuse. Participation in other investigational drugs or device clinical trials within 30 days prior to Screening. Any decision by the Investigator to terminate a subject in screening or declare any subject ineligible for any sound medical reason.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Santen Pharmaceutical Co., Ltd Clinical Operations
Phone
+81-6-4802-9341
Email
clinical@santen.co.jp
Facility Information:
Facility Name
Eyecare Nagoya
City
Aichi
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kitanagoya Eye Clinic
City
Aichi
Country
Japan
Individual Site Status
Recruiting
Facility Name
Takahashi Eye Clinic
City
Aichi
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kawabata Eye Clinic
City
Chiba
Country
Japan
Individual Site Status
Recruiting
Facility Name
Mitsuhashi Eye Clinic
City
Chiba
Country
Japan
Individual Site Status
Recruiting
Facility Name
Shisui Ophthalmology Clinic
City
Chiba
Country
Japan
Individual Site Status
Recruiting
Facility Name
Takeda Eye Clinic
City
Hokkaido
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kanamori Eye Clinic
City
Hyogo
Country
Japan
Individual Site Status
Recruiting
Facility Name
Dannoue Eye Clinic
City
Kanagawa
Country
Japan
Individual Site Status
Recruiting
Facility Name
Hodogaya iina Eye Clinic
City
Kanagawa
Country
Japan
Individual Site Status
Recruiting
Facility Name
Honda Eye Clinic
City
Kanagawa
Country
Japan
Individual Site Status
Recruiting
Facility Name
Yokosuka Chuoh Eye Clinic
City
Kanagawa
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kengun Sakuragi Eye Clinic
City
Kumamoto
Country
Japan
Individual Site Status
Recruiting
Facility Name
Hideyuki Eye Clinic
City
Miyagi
Country
Japan
Individual Site Status
Recruiting
Facility Name
Iwashita Eye Clinic
City
Osaka
Country
Japan
Individual Site Status
Recruiting
Facility Name
Maeda Eye Clinic
City
Osaka
Country
Japan
Individual Site Status
Recruiting
Facility Name
Nishi Eye Hospital
City
Osaka
Country
Japan
Individual Site Status
Recruiting
Facility Name
OCROM Clinic
City
Osaka
Country
Japan
Individual Site Status
Recruiting
Facility Name
Onoe Eye Clinic
City
Osaka
Country
Japan
Individual Site Status
Recruiting
Facility Name
Sugasawa Eye Clinic
City
Osaka
Country
Japan
Individual Site Status
Recruiting
Facility Name
Sugiura Eye Clinic
City
Osaka
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tahara Eye Clinic
City
Osaka
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tane Memorial Eye Hospital
City
Osaka
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kawaguchi Aozora Eye Clinic
City
Saitama
Country
Japan
Individual Site Status
Recruiting
Facility Name
Omiya Hamada Eye Clinic West entrance Branch
City
Saitama
Country
Japan
Individual Site Status
Recruiting
Facility Name
Omiya Hamada Eye Clinic
City
Saitama
Country
Japan
Individual Site Status
Recruiting
Facility Name
Shibuya Ophthalmology Clinic
City
Saitama
Country
Japan
Individual Site Status
Recruiting
Facility Name
Muramatsu Eye Clinic
City
Shizuoka
Country
Japan
Individual Site Status
Recruiting
Facility Name
Nakamura Eye Clinic
City
Shizuoka
Country
Japan
Individual Site Status
Recruiting
Facility Name
Ono Ophthalmic Clinic
City
Shizuoka
Country
Japan
Individual Site Status
Recruiting
Facility Name
Saito Eye Clinic
City
Shizuoka
Country
Japan
Individual Site Status
Recruiting
Facility Name
Yoshimura Eye & Internal Medical Clinic
City
Shizuoka
Country
Japan
Individual Site Status
Recruiting
Facility Name
Dogenzaka Kato Eye Clinic
City
Tokyo
Country
Japan
Individual Site Status
Recruiting
Facility Name
Hashida Eye Clinic
City
Tokyo
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kakinoki Eye Clinic
City
Tokyo
Country
Japan
Individual Site Status
Recruiting
Facility Name
Seijo Clinic
City
Tokyo
Country
Japan
Individual Site Status
Recruiting
Facility Name
Shimizu Eye Clinic
City
Tokyo
Country
Japan
Individual Site Status
Recruiting
Facility Name
Shirayama Eye Clinic
City
Tokyo
Country
Japan
Individual Site Status
Recruiting
Facility Name
Suitengu Fujita Ophthalmo Clinic
City
Tokyo
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tamagawa Eye Clinic
City
Tokyo
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tokiwadai Muranaka Eye Clinic
City
Tokyo
Country
Japan
Individual Site Status
Recruiting
Facility Name
Ueda Eye Clinic
City
Tokyo
Country
Japan
Individual Site Status
Recruiting
Facility Name
Watanabe Eye Clinic
City
Tokyo
Country
Japan
Individual Site Status
Recruiting
Facility Name
IMAI Eye Clinic
City
Yamanashi
Country
Japan
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Comparative Confirmatory Study of STN1012600 in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension

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