Clinical trial NCT05495061: A Comparative Confirmatory Study of STN1012600 in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension
Official title: A Phase III, Randomized, Observer-Masked, Active-Controlled, Parallel-Group, Multicenter Study Assessing the Efficacy and Safety of STN1012600 Ophthalmic Solution 0.002% Compared With Latanoprost 0.005% in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension (Angel-J1 Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Primary Open Angle Glaucoma, Ocular Hypertension
Lead sponsor: Santen Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-08-10
Enrollment: 325
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in mean diurnal intraocular pressure
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Aichi
country: Japan
facility: Eyecare Nagoya
city: Aichi
country: Japan
facility: Kitanagoya Eye Clinic
city: Aichi
country: Japan
facility: Takahashi Eye Clinic
city: Chiba
country: Japan
facility: Kawabata Eye Clinic
city: Chiba
country: Japan
facility: Mitsuhashi Eye Clinic
city: Chiba
country: Japan
facility: Shisui Ophthalmology Clinic
city: Hokkaido
country: Japan
facility: Takeda Eye Clinic
city: Hyogo
country: Japan
facility: Kanamori Eye Clinic
city: Kanagawa
country: Japan
facility: Dannoue Eye Clinic
city: Kanagawa
country: Japan
facility: Hodogaya iina Eye Clinic
city: Kanagawa
country: Japan
facility: Honda Eye Clinic
city: Kanagawa
country: Japan
facility: Yokosuka Chuoh Eye Clinic
city: Kumamoto
country: Japan
facility: Kengun Sakuragi Eye Clinic
city: Miyagi
country: Japan
facility: Hideyuki Eye Clinic
city: Osaka
country: Japan
facility: Iwashita Eye Clinic
city: Osaka
country: Japan
facility: Maeda Eye Clinic
city: Osaka
country: Japan
facility: Nishi Eye Hospital
city: Osaka
country: Japan
facility: OCROM Clinic
city: Osaka
country: Japan
facility: Onoe Eye Clinic
city: Osaka
country: Japan
facility: Sugasawa Eye Clinic
city: Osaka
country: Japan
facility: Sugiura Eye Clinic
city: Osaka
country: Japan
facility: Tahara Eye Clinic
city: Osaka
country: Japan
facility: Tane Memorial Eye Hospital
city: Saitama
country: Japan
facility: Kawaguchi Aozora Eye Clinic
city: Saitama
country: Japan
facility: Omiya Hamada Eye Clinic West entrance Branch
city: Saitama
country: Japan
facility: Omiya Hamada Eye Clinic
city: Saitama
country: Japan
facility: Shibuya Ophthalmology Clinic
city: Shizuoka
country: Japan
facility: Muramatsu Eye Clinic
city: Shizuoka
country: Japan
facility: Nakamura Eye Clinic
city: Shizuoka
country: Japan
facility: Ono Ophthalmic Clinic
city: Shizuoka
country: Japan
facility: Saito Eye Clinic
city: Shizuoka
country: Japan
facility: Yoshimura Eye & Internal Medical Clinic
city: Tokyo
country: Japan
facility: Dogenzaka Kato Eye Clinic
city: Tokyo
country: Japan
facility: Hashida Eye Clinic
city: Tokyo
country: Japan
facility: Kakinoki Eye Clinic
city: Tokyo
country: Japan
facility: Seijo Clinic
city: Tokyo
country: Japan
facility: Shimizu Eye Clinic
city: Tokyo
country: Japan
facility: Shirayama Eye Clinic
city: Tokyo
country: Japan
facility: Suitengu Fujita Ophthalmo Clinic
city: Tokyo
country: Japan
facility: Tamagawa Eye Clinic
city: Tokyo
country: Japan
facility: Tokiwadai Muranaka Eye Clinic
city: Tokyo
country: Japan
facility: Ueda Eye Clinic
city: Tokyo
country: Japan
facility: Watanabe Eye Clinic
city: Yamanashi
country: Japan
facility: IMAI Eye Clinic
Study officials:
References: