Clinical trial NCT05503901: A Long Term Study of STN1012600 in Subjects With Open Angle Glaucoma or Ocular Hypertension
Official title: An Open-Label, Long-Term Phase III Study of STN1012600 Ophthalmic Solution Alone and in Combination With Timolol Ophthalmic Solution, in Subjects With Open Angle Glaucoma or Ocular Hypertension (Angel-J2 Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Open Angle Glaucoma, Ocular Hypertension
Lead sponsor: Santen Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-08-17
Enrollment: 131
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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in mean diurnal intraocular pressure
timeFrame: 52 weeks
measure: Percent change from baseline in mean diurnal intraocular pressure
timeFrame: 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Aichi
country: Japan
facility: Kitanagoya Eye Clinic
city: Aichi
country: Japan
facility: Miyake Eye Hospital
city: Aichi
country: Japan
facility: Nagasaka Eye Clinic
city: Fukuoka
country: Japan
facility: Eto Eye Clinic
city: Hiroshima
country: Japan
facility: Minamoto Eye Clinic
city: Ibaraki
country: Japan
facility: Matsumoto Eye Clinic
city: Kagoshima
country: Japan
facility: IGO Ophthalmic Clinic
city: Kanagawa
country: Japan
facility: Ohguchi Ophthalmic Clinic
city: Kanagawa
country: Japan
facility: Smile Eye Clinic
city: Osaka
country: Japan
facility: Inamoto Eye Clinic
city: Osaka
country: Japan
facility: Kubota Eye Clinic
city: Osaka
country: Japan
facility: Nishi Eye Hospital
city: Osaka
country: Japan
facility: Onoe Eye Clinic
city: Saitama
country: Japan
facility: Red Cross Ogawa Hospital
city: Shizuoka
country: Japan
facility: Nakajima Eye Clinic
city: Tokyo
country: Japan
facility: Hashida Eye Clinic
city: Tokyo
country: Japan
facility: Seijo Clinic
city: Tokyo
country: Japan
facility: Sinzyuku Eye Clinic
Study officials:
References: