Clinical trial
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)
Name
101260006LT
Description
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.
Trial arms
Trial start
2022-08-08
Estimated PCD
2024-01-31
Trial end
2024-01-31
Status
Recruiting
Phase
Early phase I
Treatment
STN1012600 ophthalmic solution 0.002%
1 drop STN1012600 ophthalmic solution 0.002% once daily for 52 weeks
Arms:
Group 1: STN1012600 0.002%
STN1012600 ophthalmic solution 0.002%
1 drop STN1012600 ophthalmic solution 0.002% once daily for 52 weeks
Arms:
Group 2: STN1012600 0.002%
STN1012600 ophthalmic solution 0.002% and Timolol ophthalmic solution 0.5%
1 drop STN1012600 ophthalmic solution 0.002% once daily for 52 weeks and 1 drop Timolol ophthalmic solution 0.5% twice daily for 52 weeks
Arms:
Group 3: STN1012600 0.002% + Timolol 0.5%
Size
138
Primary endpoint
Change from baseline in mean diurnal intraocular pressure
52 weeks
Percent change from baseline in mean diurnal intraocular pressure
52 weeks
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 138, 'type': 'ESTIMATED'}}
Updated at
2023-02-09
1 organization
2 products
2 indications
Product
STN1012600Indication
GlaucomaIndication
ocular hypertensionOrganization
Santen Pharmaceutical