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

Primary Purpose

Open Angle Glaucoma, Ocular Hypertension

Status
Recruiting
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
STN1012600 ophthalmic solution 0.002%
STN1012600 ophthalmic solution 0.002%
STN1012600 ophthalmic solution 0.002% and Timolol ophthalmic solution 0.5%
Sponsored by
Santen Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for 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 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.

Sites / Locations

  • Kitanagoya Eye ClinicRecruiting
  • Miyake Eye HospitalRecruiting
  • Nagasaka Eye ClinicRecruiting
  • Eto Eye ClinicRecruiting
  • Minamoto Eye ClinicRecruiting
  • Matsumoto Eye ClinicRecruiting
  • IGO Ophthalmic ClinicRecruiting
  • Ohguchi Ophthalmic ClinicRecruiting
  • Smile Eye ClinicRecruiting
  • Inamoto Eye ClinicRecruiting
  • Kubota Eye ClinicRecruiting
  • Nishi Eye HospitalRecruiting
  • Onoe Eye ClinicRecruiting
  • Red Cross Ogawa HospitalRecruiting
  • Nakajima Eye ClinicRecruiting
  • Hashida Eye ClinicRecruiting
  • Seijo ClinicRecruiting
  • Sinzyuku Eye ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Group 1: STN1012600 0.002%

Group 2: STN1012600 0.002%

Group 3: STN1012600 0.002% + Timolol 0.5%

Arm Description

Outcomes

Primary Outcome Measures

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

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
NCT05503901
Brief Title
A Long Term Study of STN1012600 in Subjects With Open Angle Glaucoma or Ocular Hypertension
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 8, 2022 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
January 31, 2024 (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 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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
138 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1: STN1012600 0.002%
Arm Type
Experimental
Arm Title
Group 2: STN1012600 0.002%
Arm Type
Experimental
Arm Title
Group 3: STN1012600 0.002% + Timolol 0.5%
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
STN1012600 ophthalmic solution 0.002%
Intervention Description
1 drop STN1012600 ophthalmic solution 0.002% once daily for 52 weeks
Intervention Type
Drug
Intervention Name(s)
STN1012600 ophthalmic solution 0.002%
Intervention Description
1 drop STN1012600 ophthalmic solution 0.002% once daily for 52 weeks
Intervention Type
Drug
Intervention Name(s)
STN1012600 ophthalmic solution 0.002% and Timolol ophthalmic solution 0.5%
Intervention Description
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
Primary Outcome Measure Information:
Title
Change from baseline in mean diurnal intraocular pressure
Description
Change from baseline in mean diurnal intraocular pressure at each post-baseline visit
Time Frame
52 weeks
Title
Percent change from baseline in mean diurnal intraocular pressure
Description
Percent change from baseline in mean diurnal intraocular pressure at each post-baseline visit
Time Frame
52 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 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.
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
Kitanagoya Eye Clinic
City
Aichi
Country
Japan
Individual Site Status
Recruiting
Facility Name
Miyake Eye Hospital
City
Aichi
Country
Japan
Individual Site Status
Recruiting
Facility Name
Nagasaka Eye Clinic
City
Aichi
Country
Japan
Individual Site Status
Recruiting
Facility Name
Eto Eye Clinic
City
Fukuoka
Country
Japan
Individual Site Status
Recruiting
Facility Name
Minamoto Eye Clinic
City
Hiroshima
Country
Japan
Individual Site Status
Recruiting
Facility Name
Matsumoto Eye Clinic
City
Ibaraki
Country
Japan
Individual Site Status
Recruiting
Facility Name
IGO Ophthalmic Clinic
City
Kagoshima
Country
Japan
Individual Site Status
Recruiting
Facility Name
Ohguchi Ophthalmic Clinic
City
Kanagawa
Country
Japan
Individual Site Status
Recruiting
Facility Name
Smile Eye Clinic
City
Kanagawa
Country
Japan
Individual Site Status
Recruiting
Facility Name
Inamoto Eye Clinic
City
Osaka
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kubota 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
Onoe Eye Clinic
City
Osaka
Country
Japan
Individual Site Status
Recruiting
Facility Name
Red Cross Ogawa Hospital
City
Saitama
Country
Japan
Individual Site Status
Recruiting
Facility Name
Nakajima Eye Clinic
City
Shizuoka
Country
Japan
Individual Site Status
Recruiting
Facility Name
Hashida Eye Clinic
City
Tokyo
Country
Japan
Individual Site Status
Recruiting
Facility Name
Seijo Clinic
City
Tokyo
Country
Japan
Individual Site Status
Recruiting
Facility Name
Sinzyuku Eye Clinic
City
Tokyo
Country
Japan
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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