Open Angle Glaucoma, Ocular Hypertension
Conditions
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.
Interventions
DRUGSTN1012600 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
1 drop STN1012600 ophthalmic solution 0.002% once daily for 52 weeks
Sponsors
Santen Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in mean diurnal intraocular pressure | 52 weeks | Change from baseline in mean diurnal intraocular pressure at each post-baseline visit |
| Percent change from baseline in mean diurnal intraocular pressure | 52 weeks | Percent change from baseline in mean diurnal intraocular pressure at each post-baseline visit |
Countries
Japan
Outcome results
None listed