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

NCT05495061 | Completed Phase 3

• 1 other identifier: 101260005LT
• Study Type: interventional
• Target: 325
• Locations: 1 country
• Sites: 44

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.

Conditions

Primary Open Angle Glaucoma, Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

• Change from baseline in mean diurnal intraocular pressure

  Change from baseline in mean diurnal intraocular pressure at Week 4

  4 weeks

Study Arms (2)

STN1012600 0.002%

EXPERIMENTAL

Drug: STN1012600 ophthalmic solution 0.002%

Latanoprost 0.005%

ACTIVE COMPARATOR

Drug: Latanoprost ophthalmic solution 0.005%

Interventions

STN1012600 ophthalmic solution 0.002% DRUG

1 drop STN1012600 ophthalmic solution 0.002% once daily for 3 months

STN1012600 0.002%

Latanoprost ophthalmic solution 0.005% DRUG

1 drop Latanoprost ophthalmic solution 0.005% once daily for 3 months

Latanoprost 0.005%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Santen Pharmaceutical Co., Ltd.: lead

Study Sites (44)

Eyecare Nagoya

Aichi, Japan

Location

Kitanagoya Eye Clinic

Aichi, Japan

Location

Takahashi Eye Clinic

Aichi, Japan

Location

Kawabata Eye Clinic

Chiba, Japan

Location

Mitsuhashi Eye Clinic

Chiba, Japan

Location

Shisui Ophthalmology Clinic

Chiba, Japan

Location

Takeda Eye Clinic

Hokkaido, Japan

Location

Kanamori Eye Clinic

Hyōgo, Japan

Location

Dannoue Eye Clinic

Kanagawa, Japan

Location

Hodogaya iina Eye Clinic

Kanagawa, Japan

Location

Honda Eye Clinic

Kanagawa, Japan

Location

Yokosuka Chuoh Eye Clinic

Kanagawa, Japan

Location

Kengun Sakuragi Eye Clinic

Kumamoto, Japan

Location

Hideyuki Eye Clinic

Miyagi, Japan

Location

Iwashita Eye Clinic

Osaka, Japan

Location

Maeda Eye Clinic

Osaka, Japan

Location

Nishi Eye Hospital

Osaka, Japan

Location

OCROM Clinic

Osaka, Japan

Location

Onoe Eye Clinic

Osaka, Japan

Location

Sugasawa Eye Clinic

Osaka, Japan

Location

Sugiura Eye Clinic

Osaka, Japan

Location

Tahara Eye Clinic

Osaka, Japan

Location

Tane Memorial Eye Hospital

Osaka, Japan

Location

Kawaguchi Aozora Eye Clinic

Saitama, Japan

Location

Omiya Hamada Eye Clinic West entrance Branch

Saitama, Japan

Location

Omiya Hamada Eye Clinic

Saitama, Japan

Location

Shibuya Ophthalmology Clinic

Saitama, Japan

Location

Muramatsu Eye Clinic

Shizuoka, Japan

Location

Nakamura Eye Clinic

Shizuoka, Japan

Location

Ono Ophthalmic Clinic

Shizuoka, Japan

Location

Saito Eye Clinic

Shizuoka, Japan

Location

Yoshimura Eye & Internal Medical Clinic

Shizuoka, Japan

Location

Dogenzaka Kato Eye Clinic

Tokyo, Japan

Location

Hashida Eye Clinic

Tokyo, Japan

Location

Kakinoki Eye Clinic

Tokyo, Japan

Location

Seijo Clinic

Tokyo, Japan

Location

Shimizu Eye Clinic

Tokyo, Japan

Location

Shirayama Eye Clinic

Tokyo, Japan

Location

Suitengu Fujita Ophthalmo Clinic

Tokyo, Japan

Location

Tamagawa Eye Clinic

Tokyo, Japan

Location

Tokiwadai Muranaka Eye Clinic

Tokyo, Japan

Location

Ueda Eye Clinic

Tokyo, Japan

Location

Watanabe Eye Clinic

Tokyo, Japan

Location

IMAI Eye Clinic

Yamanashi, Japan

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2022
• First Posted: August 10, 2022
• Study Start: August 9, 2022
• Primary Completion: April 18, 2023
• Study Completion: April 18, 2023
• Last Updated: December 5, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

JP (44)