Primary Open Angle GlaucomaPhase 2/3NCT02623738
A Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension -AYAME Study-
A Phase 2/3 study testing DE-117 ophthalmic solution low, DE-117 ophthalmic solution high and Latanoprost ophthalmic solution 0.005% in people with Primary Open Angle Glaucoma and Ocular Hypertension, run by Santen Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial summary
The purposes of this study are to determine the optimal concentration of DE-117 ophthalmic solution compared to the placebo ophthalmic solution and to determine if intraocular pressure reduction after 4 weeks of treatment with DE-117 ophthalmic solution is non-inferior to latanoprost ophthalmic solution 0.005%. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Primary Open Angle Glaucoma, Ocular Hypertension
- What is being tested?
- DE-117 ophthalmic solution low, DE-117 ophthalmic solution high and Latanoprost ophthalmic solution 0.005%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 253 participants
- Where
- 1 siteJapan
- Study dates
- 6 Dec 2015to 10 Feb 2017
- Phase
- Phase 2/3
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary open angle glaucoma or ocular hypertension
Who cannot join
- Patients at risk of progression of visual field loss
- Patients with severe visual field defect
- Patients with any diseases that preclude participation in this study for safety reasons
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II/III Randomized, Double-masked, Controlled, Parallel Group, Multicenter Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension -AYAME Study-
The purposes of this study are to determine the optimal concentration of DE-117 ophthalmic solution compared to the placebo ophthalmic solution and to determine if intraocular pressure reduction after 4 weeks of treatment with DE-117 ophthalmic solution is non-inferior to latanoprost ophthalmic solution 0.005%.
- Conditions
- Primary Open Angle Glaucoma, Ocular Hypertension
- Being tested
- Placebo ophthalmic solution, DE-117 ophthalmic solution low, DE-117 ophthalmic solution high, 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.
Placebo ophthalmic solutionDrug
DE-117 ophthalmic solution lowDrug
DE-117 ophthalmic solution highDrug
Latanoprost ophthalmic solution 0.005%Drug
Also called Latanoprost
| Study group | Role | What they receive |
|---|---|---|
| Placebo ophthalmic solution | Placebo comparator | Eyedrop Receives: Drug: Placebo ophthalmic solution |
| DE-117 ophthalmic solution low | Experimental | Eyedrop Receives: Drug: DE-117 ophthalmic solution low |
| DE-117 ophthalmic solution high | Experimental | Eyedrop Receives: Drug: DE-117 ophthalmic solution high |
| Latanoprost ophthalmic solution 0.005% | Active comparator | Eyedrop Receives: Drug: Latanoprost ophthalmic solution 0.005% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2015 (estimated)
- Study start6 Dec 2015
- Primary completion10 Feb 2017
- Study completion10 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Open Angle GlaucomaStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 253 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
- NCT02623738
- Sponsor's protocol ID
- 01171503
- Status last verified
- Nov 2017
- First submitted
- 3 Dec 2015
- Last updated
- 20 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Aihara M, Lu F, Kawata H, Iwata A, Odani-Kawabata N, Shams NK. Omidenepag Isopropyl Versus Latanoprost in Primary Open-Angle Glaucoma and Ocular Hypertension: The Phase 3 AYAME Study. Am J Ophthalmol. 2020 Dec;220:53-63. doi: 10.1016/j.ajo.2020.06.003. Epub 2020 Jun 10.
PubMed 32533949
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II/III Randomized, Double-masked, Controlled, Parallel Group, Multicenter Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension -AYAME Study-
- ClinicalTrials.gov ID
- NCT02623738
- Acronym / sponsor ID
- 01171503
- Conditions
- Primary Open Angle Glaucoma, Ocular Hypertension
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 253 participants (actual)
- Lead sponsor
- Santen Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Dec 2015 (actual)
- Primary completion
- 10 Feb 2017 (actual)
- Study completion
- 10 Feb 2017 (actual)
- First posted
- 8 Dec 2015 (estimated)
- 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.
The purposes of this study are to determine the optimal concentration of DE-117 ophthalmic solution compared to the placebo ophthalmic solution and to determine if intraocular pressure reduction after 4 weeks of treatment with DE-117 ophthalmic solution is non-inferior to latanoprost ophthalmic solution 0.005%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo ophthalmic solution | Placebo comparator | Drug: Placebo ophthalmic solutionEyedrop |
| DE-117 ophthalmic solution low | Experimental | Drug: DE-117 ophthalmic solution lowEyedrop |
| DE-117 ophthalmic solution high | Experimental | Drug: DE-117 ophthalmic solution highEyedrop |
| Latanoprost ophthalmic solution 0.005% | Active comparator | Drug: Latanoprost ophthalmic solution 0.005%Eyedrop |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Primary open angle glaucoma or ocular hypertension
Key exclusion criteria (3 listed)
- Patients at risk of progression of visual field loss
- Patients with severe visual field defect
- Patients with any diseases that preclude participation in this study for safety reasons
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 |
|---|---|---|
| Placebo ophthalmic solution | Drug | Placebo ophthalmic solution |
| DE-117 ophthalmic solution low | Drug | DE-117 ophthalmic solution low |
| DE-117 ophthalmic solution high | Drug | DE-117 ophthalmic solution high |
| Latanoprost ophthalmic solution 0.005%Also: Latanoprost | Drug | Latanoprost ophthalmic solution 0.005% |
Primary outcome
Intraocular pressure
Time frame: 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 20 Nov 2017.
- Derived from this study: PubMed 32533949Aihara M, Lu F, Kawata H, Iwata A, Odani-Kawabata N, Shams NK. Omidenepag Isopropyl Versus Latanoprost in Primary Open-Angle Glaucoma and Ocular Hypertension: The Phase 3 AYAME Study. Am J Ophthalmol. 2020 Dec;220:53-63. doi: 10.1016/j.ajo.2020.06.003. Epub 2020 Jun 10.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing DE-117 ophthalmic solution low, DE-117 ophthalmic solution high and Latanoprost ophthalmic solution 0.005% in people with Primary Open Angle Glaucoma and Ocular Hypertension, run by Santen Pharmaceutical Co., Ltd. at 1 site 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 1 inclusion and 3 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 20 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Intraocular pressure (time frame: Week 4). 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 NCT02623738, which also lists 1 linked publication.
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 20 Nov 2017; AzTrials last refreshed its copy on 7 Nov 2026.