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

• Sponsor: Santen Pharmaceutical Co., Ltd. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05495061
• Collaborator: (none)
• Enrollment: 300
• Locations: 43
• Arms: 2
• Anticipated Duration (Months): 9.7
• Patients Per Site: 7
• Patients Per Site Per Month: 0.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Primary Open Angle Glaucoma, Ocular Hypertension	Drug: STN1012600 ophthalmic solution 0.002%; Drug: Latanoprost ophthalmic solution 0.005%	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: Aug 9, 2022
• Anticipated Primary Completion Date: May 31, 2023
• Anticipated Study Completion Date: May 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change from baseline in mean diurnal intraocular pressure [4 weeks]

   Change from baseline in mean diurnal intraocular pressure at Week 4

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eyecare Nagoya	Aichi		Japan
2	Kitanagoya Eye Clinic	Aichi		Japan
3	Takahashi Eye Clinic	Aichi		Japan
4	Kawabata Eye Clinic	Chiba		Japan
5	Mitsuhashi Eye Clinic	Chiba		Japan
6	Shisui Ophthalmology Clinic	Chiba		Japan
7	Takeda Eye Clinic	Hokkaido		Japan
8	Kanamori Eye Clinic	Hyogo		Japan
9	Dannoue Eye Clinic	Kanagawa		Japan
10	Hodogaya iina Eye Clinic	Kanagawa		Japan
11	Honda Eye Clinic	Kanagawa		Japan
12	Yokosuka Chuoh Eye Clinic	Kanagawa		Japan
13	Kengun Sakuragi Eye Clinic	Kumamoto		Japan
14	Hideyuki Eye Clinic	Miyagi		Japan
15	Iwashita Eye Clinic	Osaka		Japan
16	Maeda Eye Clinic	Osaka		Japan
17	Nishi Eye Hospital	Osaka		Japan
18	Onoe Eye Clinic	Osaka		Japan
19	Sugasawa Eye Clinic	Osaka		Japan
20	Sugiura Eye Clinic	Osaka		Japan
21	Tahara Eye Clinic	Osaka		Japan
22	Tane Memorial Eye Hospital	Osaka		Japan
23	Kawaguchi Aozora Eye Clinic	Saitama		Japan
24	Omiya Hamada Eye Clinic West entrance Branch	Saitama		Japan
25	Omiya Hamada Eye Clinic	Saitama		Japan
26	Shibuya Ophthalmology Clinic	Saitama		Japan
27	Muramatsu Eye Clinic	Shizuoka		Japan
28	Nakamura Eye Clinic	Shizuoka		Japan
29	Ono Ophthalmic Clinic	Shizuoka		Japan
30	Saito Eye Clinic	Shizuoka		Japan
31	Yoshimura Eye & Internal Medical Clinic	Shizuoka		Japan
32	Dogenzaka Kato Eye Clinic	Tokyo		Japan
33	Hashida Eye Clinic	Tokyo		Japan
34	Kakinoki Eye Clinic	Tokyo		Japan
35	Seijo Clinic	Tokyo		Japan
36	Shimizu Eye Clinic	Tokyo		Japan
37	Shirayama Eye Clinic	Tokyo		Japan
38	Suitengu Fujita Ophthalmo Clinic	Tokyo		Japan
39	Tamagawa Eye Clinic	Tokyo		Japan
40	Tokiwadai Muranaka Eye Clinic	Tokyo		Japan
41	Ueda Eye Clinic	Tokyo		Japan
42	Watanabe Eye Clinic	Tokyo		Japan
43	IMAI Eye Clinic	Yamanashi		Japan

Sponsors and Collaborators

• Santen Pharmaceutical Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Santen Pharmaceutical Co., Ltd.
• ClinicalTrials.gov Identifier: NCT05495061
• Other Study ID Numbers: 101260005LT
• First Posted: Aug 10, 2022
• Last Update Posted: Aug 10, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Pharmaceutical Solutions; Latanoprost; Ophthalmic Solutions

Study Results

No Results Posted as of Aug 10, 2022