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

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)

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.

Study Overview

• Status: Completed
• Conditions: Primary Open Angle Glaucoma, Ocular Hypertension
• Intervention / Treatment: Drug: STN1012600 ophthalmic solution 0.002%; Drug: Latanoprost ophthalmic solution 0.005%

• Study Type: Interventional
• Enrollment (Actual): 325
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Aichi, Japan
    • Eyecare Nagoya
  • Aichi, Japan
    • Kitanagoya Eye Clinic
  • Aichi, Japan
    • Takahashi Eye Clinic
  • Chiba, Japan
    • Kawabata Eye Clinic
  • Chiba, Japan
    • Mitsuhashi Eye Clinic
  • Chiba, Japan
    • Shisui Ophthalmology Clinic
  • Hokkaido, Japan
    • Takeda Eye Clinic
  • Hyogo, Japan
    • Kanamori Eye Clinic
  • Kanagawa, Japan
    • Dannoue Eye Clinic
  • Kanagawa, Japan
    • Hodogaya iina Eye Clinic
  • Kanagawa, Japan
    • Honda Eye Clinic
  • Kanagawa, Japan
    • Yokosuka Chuoh Eye Clinic
  • Kumamoto, Japan
    • Kengun Sakuragi Eye Clinic
  • Miyagi, Japan
    • Hideyuki Eye Clinic
  • Osaka, Japan
    • Iwashita Eye Clinic
  • Osaka, Japan
    • Maeda Eye Clinic
  • Osaka, Japan
    • Nishi Eye Hospital
  • Osaka, Japan
    • OCROM Clinic
  • Osaka, Japan
    • Onoe Eye Clinic
  • Osaka, Japan
    • Sugasawa Eye Clinic
  • Osaka, Japan
    • Sugiura Eye Clinic
  • Osaka, Japan
    • Tahara Eye Clinic
  • Osaka, Japan
    • Tane Memorial Eye Hospital
  • Saitama, Japan
    • Kawaguchi Aozora Eye Clinic
  • Saitama, Japan
    • Omiya Hamada Eye Clinic West entrance Branch
  • Saitama, Japan
    • Omiya Hamada Eye Clinic
  • Saitama, Japan
    • Shibuya Ophthalmology Clinic
  • Shizuoka, Japan
    • Muramatsu Eye Clinic
  • Shizuoka, Japan
    • Nakamura Eye Clinic
  • Shizuoka, Japan
    • Ono Ophthalmic Clinic
  • Shizuoka, Japan
    • Saito Eye Clinic
  • Shizuoka, Japan
    • Yoshimura Eye & Internal Medical Clinic
  • Tokyo, Japan
    • Dogenzaka Kato Eye Clinic
  • Tokyo, Japan
    • Hashida Eye Clinic
  • Tokyo, Japan
    • Kakinoki Eye Clinic
  • Tokyo, Japan
    • Seijo Clinic
  • Tokyo, Japan
    • Shimizu Eye Clinic
  • Tokyo, Japan
    • Shirayama Eye Clinic
  • Tokyo, Japan
    • Suitengu Fujita Ophthalmo Clinic
  • Tokyo, Japan
    • Tamagawa Eye Clinic
  • Tokyo, Japan
    • Tokiwadai Muranaka Eye Clinic
  • Tokyo, Japan
    • Ueda Eye Clinic
  • Tokyo, Japan
    • Watanabe Eye Clinic
  • Yamanashi, Japan
    • IMAI Eye Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: STN1012600 0.002%	Drug: STN1012600 ophthalmic solution 0.002%; 1 drop STN1012600 ophthalmic solution 0.002% once daily for 3 months
Active Comparator: Latanoprost 0.005%	Drug: Latanoprost ophthalmic solution 0.005%; 1 drop Latanoprost ophthalmic solution 0.005% once daily for 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in mean diurnal intraocular pressure	Change from baseline in mean diurnal intraocular pressure at Week 4	4 weeks

Collaborators and Investigators

• Sponsor: Santen Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2022
• Primary Completion (Actual): April 18, 2023
• Study Completion (Actual): April 18, 2023

Study Registration Dates

• First Submitted: August 9, 2022
• First Submitted That Met QC Criteria: August 9, 2022
• First Posted (Actual): August 10, 2022

Study Record Updates

• Last Update Posted (Actual): December 5, 2023
• Last Update Submitted That Met QC Criteria: December 3, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Ophthalmic Solutions; Pharmaceutical Solutions; Latanoprost
• Other Study ID Numbers: 101260005LT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No