NCT05503901CompletedPhase 3
A Long Term Study of STN1012600 in Subjects With Open Angle Glaucoma or Ocular Hypertension
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)
Source: ClinicalTrials.gov · Last updated 15 Jul 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 131 (actual)
- First submitted
- 9 Aug 2022
- Start date
- 8 Aug 2022
- Primary completion date
- 30 Jan 2024
- Lead sponsor
- Santen Pharmaceutical Co., Ltd.
- Diseases
- Glaucoma, High blood pressure
- NCT number
- NCT05503901
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 131
- From 8 Aug 2022 to the primary completion date, 30 Jan 2024
- 18 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subjects with known or suspected drug or alcohol abuse.
- Participation in other investigational drugs or device clinical trials within 30 days prior to Screening.
Other illness
- 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.
Other
- Females who are pregnant, nursing, or planning a pregnancy.
- Any decision by the Investigator to terminate a subject in screening or declare any subject ineligible for any sound medical reason.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (18)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Miyake Eye Hospital Coordinator of this site? Confirm its status | Aichi | Japan | Unknown status |
| Kitanagoya Eye Clinic Coordinator of this site? Confirm its status | Aichi | Japan | Unknown status |
| Nagasaka Eye Clinic Coordinator of this site? Confirm its status | Aichi | Japan | Unknown status |
| Eto Eye Clinic Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| Minamoto Eye Clinic Coordinator of this site? Confirm its status | Hiroshima | Japan | Unknown status |
| Matsumoto Eye Clinic Coordinator of this site? Confirm its status | Ibaraki | Japan | Unknown status |
| IGO Ophthalmic Clinic Coordinator of this site? Confirm its status | Kagoshima | Japan | Unknown status |
| Smile Eye Clinic Coordinator of this site? Confirm its status | Kanagawa | Japan | Unknown status |
| Ohguchi Ophthalmic Clinic Coordinator of this site? Confirm its status | Kanagawa | Japan | Unknown status |
| Kubota Eye Clinic Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Nishi Eye Hospital Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Onoe Eye Clinic Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Inamoto Eye Clinic Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Red Cross Ogawa Hospital Coordinator of this site? Confirm its status | Saitama | Japan | Unknown status |
| Nakajima Eye Clinic Coordinator of this site? Confirm its status | Shizuoka | Japan | Unknown status |
| Seijo Clinic Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| Sinzyuku Eye Clinic Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| Hashida Eye Clinic Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.