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

Phase 3

Completed

• Conditions: Primary Open Angle Glaucoma, Ocular Hypertension
• Interventions: Drug: STN1012600 ophthalmic solution 0.002%; Drug: Latanoprost ophthalmic solution 0.005%

• Registration Number: NCT05495061
• Lead Sponsor: Santen Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-09
• Study First Submitted: 2022-08-09
• Study First Submitted QC: 2022-08-09
• Study First Posted: 2022-08-10
• Primary Completion: 2023-04-18
• Study Completion: 2023-04-18
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-03
• Last Update Posted: 2023-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 325

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
STN1012600 0.002%	STN1012600 ophthalmic solution 0.002%	-
Latanoprost 0.005%	Latanoprost ophthalmic solution 0.005%	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in mean diurnal intraocular pressure	4 weeks	Change from baseline in mean diurnal intraocular pressure at Week 4

Trial Locations

Locations (44)

Eyecare Nagoya; 🇯🇵 Aichi, Japan

Kitanagoya Eye Clinic; 🇯🇵 Aichi, Japan

Takahashi Eye Clinic; 🇯🇵 Aichi, Japan

Kawabata Eye Clinic; 🇯🇵 Chiba, Japan

Mitsuhashi Eye Clinic; 🇯🇵 Chiba, Japan

Shisui Ophthalmology Clinic; 🇯🇵 Chiba, Japan

Takeda Eye Clinic; 🇯🇵 Hokkaido, Japan

Kanamori Eye Clinic; 🇯🇵 Hyogo, Japan

Dannoue Eye Clinic; 🇯🇵 Kanagawa, Japan

Hodogaya iina Eye Clinic; 🇯🇵 Kanagawa, Japan

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