A Comparative Confirmatory Study of STN1012600 in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension
- Conditions
- Primary Open Angle Glaucoma, Ocular Hypertension
- Interventions
- Drug: STN1012600 ophthalmic solution 0.002%
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 325
- 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.
- 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (44)
Maeda Eye Clinic
🇯🇵Osaka, Japan
IMAI Eye Clinic
🇯🇵Yamanashi, Japan
Mitsuhashi Eye Clinic
🇯🇵Chiba, Japan
Dannoue Eye Clinic
🇯🇵Kanagawa, Japan
OCROM Clinic
🇯🇵Osaka, Japan
Shisui Ophthalmology Clinic
🇯🇵Chiba, Japan
Kitanagoya Eye Clinic
🇯🇵Aichi, Japan
Kawabata Eye Clinic
🇯🇵Chiba, Japan
Takeda Eye Clinic
🇯🇵Hokkaido, Japan
Nakamura Eye Clinic
🇯🇵Shizuoka, Japan
Hodogaya iina Eye Clinic
🇯🇵Kanagawa, Japan
Nishi Eye Hospital
🇯🇵Osaka, Japan
Muramatsu Eye Clinic
🇯🇵Shizuoka, Japan
Saito Eye Clinic
🇯🇵Shizuoka, Japan
Ono Ophthalmic Clinic
🇯🇵Shizuoka, Japan
Suitengu Fujita Ophthalmo Clinic
🇯🇵Tokyo, Japan
Tahara Eye Clinic
🇯🇵Osaka, Japan
Kawaguchi Aozora Eye Clinic
🇯🇵Saitama, Japan
Kakinoki Eye Clinic
🇯🇵Tokyo, Japan
Seijo Clinic
🇯🇵Tokyo, Japan
Eyecare Nagoya
🇯🇵Aichi, Japan
Kanamori Eye Clinic
🇯🇵Hyogo, Japan
Honda Eye Clinic
🇯🇵Kanagawa, Japan
Yokosuka Chuoh Eye Clinic
🇯🇵Kanagawa, Japan
Hideyuki Eye Clinic
🇯🇵Miyagi, Japan
Kengun Sakuragi Eye Clinic
🇯🇵Kumamoto, Japan
Sugasawa Eye Clinic
🇯🇵Osaka, Japan
Onoe Eye Clinic
🇯🇵Osaka, Japan
Sugiura Eye Clinic
🇯🇵Osaka, Japan
Tane Memorial Eye Hospital
🇯🇵Osaka, Japan
Omiya Hamada Eye Clinic West entrance Branch
🇯🇵Saitama, Japan
Omiya Hamada Eye Clinic
🇯🇵Saitama, Japan
Shibuya Ophthalmology Clinic
🇯🇵Saitama, Japan
Hashida Eye Clinic
🇯🇵Tokyo, Japan
Yoshimura Eye & Internal Medical Clinic
🇯🇵Shizuoka, Japan
Dogenzaka Kato Eye Clinic
🇯🇵Tokyo, Japan
Shimizu Eye Clinic
🇯🇵Tokyo, Japan
Shirayama Eye Clinic
🇯🇵Tokyo, Japan
Ueda Eye Clinic
🇯🇵Tokyo, Japan
Watanabe Eye Clinic
🇯🇵Tokyo, Japan
Tokiwadai Muranaka Eye Clinic
🇯🇵Tokyo, Japan
Tamagawa Eye Clinic
🇯🇵Tokyo, Japan
Takahashi Eye Clinic
🇯🇵Aichi, Japan
Iwashita Eye Clinic
🇯🇵Osaka, Japan