Open Angle Glaucoma, Ocular HypertensionPhase 3NCT05503901
A Long Term Study of STN1012600 in Subjects With Open Angle Glaucoma or Ocular Hypertension
A Phase 3 study testing STN1012600 ophthalmic solution 0.002% and STN1012600 ophthalmic solution 0.002% and Timolol ophthalmic solution 0.5% in people with Open Angle Glaucoma, Ocular Hypertension, run by Santen Pharmaceutical Co., Ltd. at 18 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open Angle Glaucoma, Ocular Hypertension
- What is being tested?
- STN1012600 ophthalmic solution 0.002% and STN1012600 ophthalmic solution 0.002% and Timolol ophthalmic solution 0.5%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 18 sitesJapan
- Study dates
- 8 Aug 2022to 30 Jan 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Japan18 sites
Kitanagoya Eye Clinic
Aichi
Miyake Eye Hospital
Aichi
Nagasaka Eye Clinic
Aichi
Eto Eye Clinic
Fukuoka
Minamoto Eye Clinic
Hiroshima
Matsumoto Eye Clinic
Ibaraki
IGO Ophthalmic Clinic
Kagoshima
Ohguchi Ophthalmic Clinic
Kanagawa
Smile Eye Clinic
Kanagawa
Inamoto Eye Clinic
Osaka
Kubota Eye Clinic
Osaka
Nishi Eye Hospital
Osaka
Onoe Eye Clinic
Osaka
Red Cross Ogawa Hospital
Saitama
Nakajima Eye Clinic
Shizuoka
Hashida Eye Clinic
Tokyo
Seijo Clinic
Tokyo
Sinzyuku Eye Clinic
Tokyo
About this study
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)
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.
- Conditions
- Open Angle Glaucoma, Ocular Hypertension
- Being tested
- STN1012600 ophthalmic solution 0.002%, STN1012600 ophthalmic solution 0.002% and Timolol ophthalmic solution 0.5%
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STN1012600 ophthalmic solution 0.002%Drug
1 drop STN1012600 ophthalmic solution 0.002% once daily for 52 weeks
STN1012600 ophthalmic solution 0.002%Drug
1 drop STN1012600 ophthalmic solution 0.002% once daily for 52 weeks
STN1012600 ophthalmic solution 0.002% and Timolol ophthalmic solution 0.5%Drug
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
| Study group | Role | What they receive |
|---|---|---|
| Group 1: STN1012600 0.002% | Experimental | Not described Receives: Drug: STN1012600 ophthalmic solution 0.002% |
| Group 2: STN1012600 0.002% | Experimental | Not described Receives: Drug: STN1012600 ophthalmic solution 0.002% |
| Group 3: STN1012600 0.002% + Timolol 0.5% | Experimental | Not described Receives: Drug: STN1012600 ophthalmic solution 0.002% and Timolol ophthalmic solution 0.5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in mean diurnal intraocular pressure
Change from baseline in mean diurnal intraocular pressure at each post-baseline visit
Measured: 52 weeks
Percent change from baseline in mean diurnal intraocular pressure
Percent change from baseline in mean diurnal intraocular pressure at each post-baseline visit
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start8 Aug 2022
- Primary completion30 Jan 2024
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open Angle Glaucoma, Ocular HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Santen Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05503901
- Sponsor's protocol ID
- 101260006LT
- Status last verified
- Jul 2024
- First submitted
- 9 Aug 2022
- Last updated
- 15 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05503901
- Acronym / sponsor ID
- 101260006LT
- Conditions
- Open Angle Glaucoma, Ocular Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Santen Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Aug 2022 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 17 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: STN1012600 0.002% | Experimental | Drug: STN1012600 ophthalmic solution 0.002% |
| Group 2: STN1012600 0.002% | Experimental | Drug: STN1012600 ophthalmic solution 0.002% |
| Group 3: STN1012600 0.002% + Timolol 0.5% | Experimental | Drug: STN1012600 ophthalmic solution 0.002% and Timolol ophthalmic solution 0.5% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STN1012600 ophthalmic solution 0.002%1 drop STN1012600 ophthalmic solution 0.002% once daily for 52 weeks | Drug | Group 1: STN1012600 0.002% |
| STN1012600 ophthalmic solution 0.002%1 drop STN1012600 ophthalmic solution 0.002% once daily for 52 weeks | Drug | 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 | Drug | Group 3: STN1012600 0.002% + Timolol 0.5% |
Primary outcome
Change from baseline in mean diurnal intraocular pressure
Time frame: 52 weeks
Change from baseline in mean diurnal intraocular pressure at each post-baseline visit
Percent change from baseline in mean diurnal intraocular pressure
Time frame: 52 weeks
Percent change from baseline in mean diurnal intraocular pressure at each post-baseline visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing STN1012600 ophthalmic solution 0.002% and STN1012600 ophthalmic solution 0.002% and Timolol ophthalmic solution 0.5% in people with Open Angle Glaucoma, Ocular Hypertension, run by Santen Pharmaceutical Co., Ltd. at 18 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in mean diurnal intraocular pressure (time frame: 52 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2024.