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

Sponsor

Santen Pharmaceutical Co., Ltd. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05503901

Collaborator

(none)

138

Enrollment

Locations

Arms

17.8

Anticipated Duration (Months)

8.6

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Open Angle Glaucoma, Ocular Hypertension	Drug: STN1012600 ophthalmic solution 0.002% Drug: STN1012600 ophthalmic solution 0.002% Drug: STN1012600 ophthalmic solution 0.002% and Timolol ophthalmic solution 0.5%	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

138 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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)

Actual Study Start Date :

Aug 8, 2022

Anticipated Primary Completion Date :

Jan 31, 2024

Anticipated Study Completion Date :

Jan 31, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	Country
1	Kitanagoya Eye Clinic	Aichi	Japan
2	Miyake Eye Hospital	Aichi	Japan
3	Nagasaka Eye Clinic	Aichi	Japan
4	Eto Eye Clinic	Fukuoka	Japan
5	Minamoto Eye Clinic	Hiroshima	Japan
6	Matsumoto Eye Clinic	Ibaraki	Japan
7	IGO Ophthalmic Clinic	Kagoshima	Japan
8	Ohguchi Ophthalmic Clinic	Kanagawa	Japan
9	Smile Eye Clinic	Kanagawa	Japan
10	Inamoto Eye Clinic	Osaka	Japan
11	Kubota Eye Clinic	Osaka	Japan
12	Nishi Eye Hospital	Osaka	Japan
13	Onoe Eye Clinic	Osaka	Japan
14	Nakajima Eye Clinic	Shizuoka	Japan
15	Hashida Eye Clinic	Tokyo	Japan
16	Seijo Clinic	Tokyo	Japan