A Long Term Study of STN1012600 in Subjects With Open Angle Glaucoma or Ocular Hypertension

An Open-Label, Long-Term Phase III Study of STN1012600 Ophthalmic Solution Alone and in Combination With Timolol Ophthalmic Solution, in Subjects With Open Angle Glaucoma or Ocular Hypertension (Angel-J2 Study)

To evaluate safety and the ocular hypotensive effect of STN1012600 ophthalmic solution 0.002% alone or in combination with Timolol ophthalmic solution 0.5% for 52 weeks in subjects with open angle glaucoma or ocular hypertension.

Study Overview

• Status: Recruiting
• Conditions: Open Angle Glaucoma, Ocular Hypertension
• Intervention / Treatment: Drug: STN1012600 ophthalmic solution 0.002%; Drug: STN1012600 ophthalmic solution 0.002% and Timolol ophthalmic solution 0.5%

• Study Type: Interventional
• Enrollment (Anticipated): 138
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Aichi, Japan
    • Recruiting
    • Kitanagoya Eye Clinic
  • Aichi, Japan
    • Recruiting
    • Nagasaka Eye Clinic
  • Aichi, Japan
    • Recruiting
    • MIYAKE Eye Hospital
  • Fukuoka, Japan
    • Recruiting
    • Eto Eye Clinic
  • Hiroshima, Japan
    • Recruiting
    • Minamoto Eye Clinic
  • Ibaraki, Japan
    • Recruiting
    • Matsumoto Eye Clinic
  • Kagoshima, Japan
    • Recruiting
    • IGO Ophthalmic Clinic
  • Kanagawa, Japan
    • Recruiting
    • Ohguchi Ophthalmic Clinic
  • Kanagawa, Japan
    • Recruiting
    • Smile Eye Clinic
  • Osaka, Japan
    • Recruiting
    • Inamoto Eye Clinic
  • Osaka, Japan
    • Recruiting
    • Nishi Eye Hospital
  • Osaka, Japan
    • Recruiting
    • Onoe Eye Clinic
  • Osaka, Japan
    • Recruiting
    • Kubota Eye Clinic
  • Saitama, Japan
    • Recruiting
    • Red Cross Ogawa Hospital
  • Shizuoka, Japan
    • Recruiting
    • Nakajima Eye Clinic
  • Tokyo, Japan
    • Recruiting
    • Hashida Eye Clinic
  • Tokyo, Japan
    • Recruiting
    • Seijo Clinic
  • Tokyo, Japan
    • Recruiting
    • Sinzyuku Eye Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18 years of age or older.
• Diagnosis of OAG or OHT in both eyes, or one eye with OAG 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
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group 1: STN1012600 0.002%	Drug: STN1012600 ophthalmic solution 0.002%; 1 drop STN1012600 ophthalmic solution 0.002% once daily for 52 weeks
EXPERIMENTAL: Group 2: STN1012600 0.002%	Drug: STN1012600 ophthalmic solution 0.002%; 1 drop STN1012600 ophthalmic solution 0.002% once daily for 52 weeks
EXPERIMENTAL: Group 3: STN1012600 0.002% + Timolol 0.5%	Drug: STN1012600 ophthalmic solution 0.002% and Timolol ophthalmic solution 0.5%; 1 drop STN1012600 ophthalmic solution 0.002% once daily for 52 weeks and 1 drop Timolol ophthalmic solution 0.5% twice daily for 52 weeks

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 each post-baseline visit	52 weeks
Percent change from baseline in mean diurnal intraocular pressure	Percent change from baseline in mean diurnal intraocular pressure at each post-baseline visit	52 weeks

Collaborators and Investigators

• Sponsor: Santen Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 8, 2022
• Primary Completion (ANTICIPATED): January 31, 2024
• Study Completion (ANTICIPATED): January 31, 2024

Study Registration Dates

• First Submitted: August 9, 2022
• First Submitted That Met QC Criteria: August 16, 2022
• First Posted (ACTUAL): August 17, 2022

Study Record Updates

• Last Update Posted (ESTIMATE): February 9, 2023
• Last Update Submitted That Met QC Criteria: February 8, 2023
• Last Verified: February 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; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Timolol; Ophthalmic Solutions; Pharmaceutical Solutions
• Other Study ID Numbers: 101260006LT

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