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

Phase 3

Completed

• Conditions: Open Angle Glaucoma, Ocular Hypertension
• Interventions: Drug: STN1012600 ophthalmic solution 0.002%; Drug: STN1012600 ophthalmic solution 0.002% and Timolol ophthalmic solution 0.5%

• Registration Number: NCT05503901
• Lead Sponsor: Santen Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-08
• Study First Submitted: 2022-08-09
• Study First Submitted QC: 2022-08-16
• Study First Posted: 2022-08-17
• Primary Completion: 2024-01-30
• Study Completion: 2024-01-30
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-12
• Last Update Posted: 2024-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 131

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1: STN1012600 0.002%	STN1012600 ophthalmic solution 0.002%	-
Group 2: STN1012600 0.002%	STN1012600 ophthalmic solution 0.002%	-
Group 3: STN1012600 0.002% + Timolol 0.5%	STN1012600 ophthalmic solution 0.002% and Timolol ophthalmic solution 0.5%	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (18)

Kitanagoya Eye Clinic; 🇯🇵 Aichi, Japan

Miyake Eye Hospital; 🇯🇵 Aichi, Japan

Nagasaka Eye Clinic; 🇯🇵 Aichi, Japan

Eto Eye Clinic; 🇯🇵 Fukuoka, Japan

IGO Ophthalmic Clinic; 🇯🇵 Kagoshima, Japan

Minamoto Eye Clinic; 🇯🇵 Hiroshima, Japan

Ohguchi Ophthalmic Clinic; 🇯🇵 Kanagawa, Japan

Matsumoto Eye Clinic; 🇯🇵 Ibaraki, Japan

Smile Eye Clinic; 🇯🇵 Kanagawa, Japan

Kubota Eye Clinic; 🇯🇵 Osaka, Japan

Nishi Eye Hospital; 🇯🇵 Osaka, Japan

Onoe Eye Clinic; 🇯🇵 Osaka, Japan

Inamoto Eye Clinic; 🇯🇵 Osaka, Japan

Red Cross Ogawa Hospital; 🇯🇵 Saitama, Japan

Hashida Eye Clinic; 🇯🇵 Tokyo, Japan

Nakajima Eye Clinic; 🇯🇵 Shizuoka, Japan

Seijo Clinic; 🇯🇵 Tokyo, Japan

Sinzyuku Eye Clinic; 🇯🇵 Tokyo, Japan