NCT05503901

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 131 (actual)
• Sponsor: Santen Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• 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 52 weeks
DRUG	STN1012600 ophthalmic solution 0.002%	1 drop STN1012600 ophthalmic solution 0.002% once daily for 52 weeks
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

Timeline

• Start date: 2022-08-08
• Primary completion: 2024-01-30
• Completion: 2024-01-30
• First posted: 2022-08-17
• Last updated: 2024-07-15

Locations

18 sites across 1 country: Japan