NCT05495061

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 325 (actual)
• Sponsor: Santen Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Primary Open Angle Glaucoma, Ocular Hypertension

Interventions

Type	Name	Description
DRUG	STN1012600 ophthalmic solution 0.002%	1 drop STN1012600 ophthalmic solution 0.002% once daily for 3 months
DRUG	Latanoprost ophthalmic solution 0.005%	1 drop Latanoprost ophthalmic solution 0.005% once daily for 3 months

Timeline

• Start date: 2022-08-09
• Primary completion: 2023-04-18
• Completion: 2023-04-18
• First posted: 2022-08-10
• Last updated: 2023-12-05

Locations

44 sites across 1 country: Japan