Primary Open Angle Glaucoma, Ocular HypertensionPhase 3NCT05495061

A Comparative Confirmatory Study of STN1012600 in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension

A Phase 3 study testing STN1012600 ophthalmic solution 0.002% and Latanoprost ophthalmic solution 0.005% in people with Primary Open Angle Glaucoma, Ocular Hypertension, run by Santen Pharmaceutical Co., Ltd. at 44 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To investigate whether the IOP lowering efficacy of STN1012600 ophthalmic solution 0.002% is non-inferior to that of latanoprost 0.005% in subjects with POAG or OHT after treatment for 4 weeks. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Primary Open Angle Glaucoma, Ocular Hypertension
What is being tested?: STN1012600 ophthalmic solution 0.002% and Latanoprost ophthalmic solution 0.005%
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 325 participants
Where: 44 sitesJapan
Study dates: 9 Aug 2022to 18 Apr 2023
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 POAG or OHT in both eyes, or one eye with POAG 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

44 sites in 1 country.

City, postcode or hospital

44 sites in 1 country

Japan44 sites

Eyecare Nagoya
Aichi
Kitanagoya Eye Clinic
Aichi
Takahashi Eye Clinic
Aichi
Kawabata Eye Clinic
Chiba
Mitsuhashi Eye Clinic
Chiba
Shisui Ophthalmology Clinic
Chiba
Takeda Eye Clinic
Hokkaido
Kanamori Eye Clinic
Hyōgo
Dannoue Eye Clinic
Kanagawa
Hodogaya iina Eye Clinic
Kanagawa
Honda Eye Clinic
Kanagawa
Yokosuka Chuoh Eye Clinic
Kanagawa
Kengun Sakuragi Eye Clinic
Kumamoto
Hideyuki Eye Clinic
Miyagi
Iwashita Eye Clinic
Osaka
Maeda Eye Clinic
Osaka
Nishi Eye Hospital
Osaka
OCROM Clinic
Osaka
Onoe Eye Clinic
Osaka
Sugasawa Eye Clinic
Osaka
Sugiura Eye Clinic
Osaka
Tahara Eye Clinic
Osaka
Tane Memorial Eye Hospital
Osaka
Kawaguchi Aozora Eye Clinic
Saitama
Omiya Hamada Eye Clinic West entrance Branch
Saitama
Omiya Hamada Eye Clinic
Saitama
Shibuya Ophthalmology Clinic
Saitama
Muramatsu Eye Clinic
Shizuoka
Nakamura Eye Clinic
Shizuoka
Ono Ophthalmic Clinic
Shizuoka
Saito Eye Clinic
Shizuoka
Yoshimura Eye & Internal Medical Clinic
Shizuoka
Dogenzaka Kato Eye Clinic
Tokyo
Hashida Eye Clinic
Tokyo
Kakinoki Eye Clinic
Tokyo
Seijo Clinic
Tokyo
Shimizu Eye Clinic
Tokyo
Shirayama Eye Clinic
Tokyo
Suitengu Fujita Ophthalmo Clinic
Tokyo
Tamagawa Eye Clinic
Tokyo
Tokiwadai Muranaka Eye Clinic
Tokyo
Ueda Eye Clinic
Tokyo
Watanabe Eye Clinic
Tokyo
IMAI Eye Clinic
Yamanashi

Other trials in Japan

About this study

Official title: A Phase III, Randomized, Observer-Masked, Active-Controlled, Parallel-Group, Multicenter Study Assessing the Efficacy and Safety of STN1012600 Ophthalmic Solution 0.002% Compared With Latanoprost 0.005% in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension (Angel-J1 Study)

To investigate whether the IOP lowering efficacy of STN1012600 ophthalmic solution 0.002% is non-inferior to that of latanoprost 0.005% in subjects with POAG or OHT after treatment for 4 weeks.

Conditions: Primary Open Angle Glaucoma, Ocular Hypertension
Being tested: STN1012600 ophthalmic solution 0.002%, Latanoprost ophthalmic solution 0.005%
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 3 months
Latanoprost ophthalmic solution 0.005%Drug
1 drop Latanoprost ophthalmic solution 0.005% once daily for 3 months

Study groups in NCT05495061
Study group	Role	What they receive
STN1012600 0.002%	Experimental	Not described Receives: Drug: STN1012600 ophthalmic solution 0.002%
Latanoprost 0.005%	Active comparator	Not described Receives: Drug: Latanoprost ophthalmic solution 0.005%

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 Week 4
Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Aug 202218 Apr 2023

First posted10 Aug 2022
Study start9 Aug 2022
Primary completion18 Apr 2023
Study completion18 Apr 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Primary 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: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 325 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05495061
Sponsor's protocol ID: 101260005LT
Status last verified: Dec 2023
First submitted: 9 Aug 2022
Last updated: 5 Dec 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
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Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
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PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
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All Primary Open Angle Glaucoma, Ocular Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Randomized, Observer-Masked, Active-Controlled, Parallel-Group, Multicenter Study Assessing the Efficacy and Safety of STN1012600 Ophthalmic Solution 0.002% Compared With Latanoprost 0.005% in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension (Angel-J1 Study)
ClinicalTrials.gov ID: NCT05495061
Acronym / sponsor ID: 101260005LT
Conditions: Primary Open Angle Glaucoma, Ocular Hypertension
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 325 participants (actual)
Lead sponsor: Santen Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 9 Aug 2022 (actual)
Primary completion: 18 Apr 2023 (actual)
Study completion: 18 Apr 2023 (actual)
First posted: 10 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 investigate whether the IOP lowering efficacy of STN1012600 ophthalmic solution 0.002% is non-inferior to that of latanoprost 0.005% in subjects with POAG or OHT after treatment for 4 weeks.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
STN1012600 0.002%	Experimental	Drug: STN1012600 ophthalmic solution 0.002%
Latanoprost 0.005%	Active comparator	Drug: Latanoprost ophthalmic solution 0.005%

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 POAG or OHT in both eyes, or one eye with POAG 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 3 months	Drug	STN1012600 0.002%
Latanoprost ophthalmic solution 0.005%1 drop Latanoprost ophthalmic solution 0.005% once daily for 3 months	Drug	Latanoprost 0.005%

Primary outcome

Change from baseline in mean diurnal intraocular pressure
Time frame: 4 weeks
Change from baseline in mean diurnal intraocular pressure at Week 4

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 5 Dec 2023.
Individual participant dataSharing planned: No

Related trials for Primary Open Angle Glaucoma, Ocular Hypertension

RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
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Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
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Active, not recruitingObservational study
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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.

44 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 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: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05495061.

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 5 Dec 2023.