Open Angle Glaucoma or Ocular HypertensionPhase 3NCT02981446

A Phase III Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution Compared With Latanoprost Ophthalmic Solution in Subjects With OAG or OHT

A Phase 3 study testing DE-117 and Latanoprost ophthalmic solution in people with Open Angle Glaucoma or Ocular Hypertension, run by Santen Pharmaceutical Co., Ltd. at 1 site in Singapore.

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

The purpose of this study is to investigate the intraocular pressure-lowering effect and the safety of DE-117 ophthalmic solution compared with Latanoprost ophthalmic solution 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 or Ocular Hypertension
What is being tested?: DE-117 and Latanoprost ophthalmic solution
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 370 participants
Where: 1 siteSingapore
Study dates: Jan 2017to Jan 2019
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Patients with open angle glaucoma or ocular hypertension in both eyes

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.

Singapore1 site

Study site
Singapore

Other trials in Singapore

About this study

Official title: A Phase III, Randomized, Observer-Masked, Active-Controlled, Parallel-Group, Multinational and Multicenter Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution 0.002% Compared With Latanoprost Ophthalmic Solution 0.005% in Subjects With Open-Angle Glaucoma or Ocular Hypertension- PEONY Study

Conditions: Open Angle Glaucoma or Ocular Hypertension
Being tested: DE-117, Latanoprost ophthalmic solution
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.

DE-117Drug
DE-117 ophthalmic solution will be taken one drop, once daily for 3 months in both eyes.
Latanoprost ophthalmic solutionDrug
Also called Xalatan
Latanoprost ophthalmic solution will be taken one drop, once daily for 3 months in both eyes.

Study groups in NCT02981446
Study group	Role	What they receive
DE-117 ophthalmic solution	Experimental	Not described Receives: Drug: DE-117
Latanoprost ophthalmic solution 0.005%	Active comparator	Not described Receives: Drug: Latanoprost ophthalmic solution

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Diurnal IOP at Month 3
The IOP (mmHg) measured in the study eye (identified at Day 1 [baseline]) was the efficacy measure for this study. The IOP was measured using a calibrated Goldmann applanation tonometer preferably by the same Investigator (operator) and the same authorized study staff (recorder) during the study for each subject.
Measured: Month 3 (average of IOP at 3 time points: 09:00, 13:00, 17:00)

Secondary outcomes (2)

IOP at 9 Timepoints (First Key Secondary Efficacy Endpoint)
The IOP (mmHg) measured in the study eye (identified at Day 1 [baseline]) was the efficacy measure for this study. The IOP was measured using a calibrated Goldmann applanation tonometer preferably by the same Investigator (operator) and the same authorized study staff (recorder) during the study for each subject.
Measured: 09:00, 13:00, and 17:00 at Week 1, Week 6, and Month 3.
Mean Diurnal IOP at Week 1 (Second Key Secondary Endpoint)
The IOP (mmHg) measured in the study eye (identified at Day 1 [baseline]) was the efficacy measure for this study. The IOP was measured using a calibrated Goldmann applanation tonometer preferably by the same Investigator (operator) and the same authorized study staff (recorder) during the study for each subject.
Measured: Week 1

Timeline

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

Jan 2017Jan 2019

First posted5 Dec 2016 (estimated)
Study startJan 2017
Primary completionJan 2019
Study completionJan 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Open Angle Glaucoma or 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: Single blind
Who is masked: Investigator
Enrolment: 370 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02981446
Sponsor's protocol ID: 01171505
Status last verified: Jun 2019
First submitted: 1 Dec 2016
Last updated: 15 Mar 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: 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

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REGN22530 for Adults With Primary Open Angle Glaucoma or Ocular Hypertension
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All Open Angle Glaucoma or Ocular Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Mar 2024. 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, Multinational and Multicenter Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution 0.002% Compared With Latanoprost Ophthalmic Solution 0.005% in Subjects With Open-Angle Glaucoma or Ocular Hypertension- PEONY Study
ClinicalTrials.gov ID: NCT02981446
Acronym / sponsor ID: 01171505
Conditions: Open Angle Glaucoma or Ocular Hypertension
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 370 participants (actual)
Lead sponsor: Santen Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: Jan 2017 (actual)
Primary completion: Jan 2019 (actual)
Study completion: Jan 2019 (actual)
First posted: 5 Dec 2016 (estimated)
Results: Posted 15 Mar 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
DE-117 ophthalmic solution	Experimental	Drug: DE-117
Latanoprost ophthalmic solution 0.005%	Active comparator	Drug: Latanoprost ophthalmic solution

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Patients with open angle glaucoma or ocular hypertension in both eyes

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
DE-117DE-117 ophthalmic solution will be taken one drop, once daily for 3 months in both eyes.	Drug	DE-117 ophthalmic solution
Latanoprost ophthalmic solutionAlso: XalatanLatanoprost ophthalmic solution will be taken one drop, once daily for 3 months in both eyes.	Drug	Latanoprost ophthalmic solution 0.005%

Primary outcome

Mean Diurnal IOP at Month 3
Time frame: Month 3 (average of IOP at 3 time points: 09:00, 13:00, 17:00)
The IOP (mmHg) measured in the study eye (identified at Day 1 [baseline]) was the efficacy measure for this study. The IOP was measured using a calibrated Goldmann applanation tonometer preferably by the same Investigator (operator) and the same authorized study staff (recorder) during the study for each subject.

2 secondary outcomes

IOP at 9 Timepoints (First Key Secondary Efficacy Endpoint)
Time frame: 09:00, 13:00, and 17:00 at Week 1, Week 6, and Month 3.
Mean Diurnal IOP at Week 1 (Second Key Secondary Endpoint)
Time frame: Week 1

Results and safety

Results posted to the registry on 15 Mar 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
DE-117 Ophthalmic Solution	185	170
Latanoprost Ophthalmic Solution 0.005%	185	177

Primary outcome: Mean Diurnal IOP at Month 3

Time frame: Month 3 (average of IOP at 3 time points: 09:00, 13:00, 17:00). Least squares mean (Standard Error). Unit: mmHg

Measure	DE-117 Ophthalmic Solution n = 184	Latanoprost Ophthalmic Solution 0.005% n = 185
Value	17.5 (0.25)	16.8 (0.25)

Population analysed: One subject in the DE-117 arm was excluded from the FAS due to no data for at least 1 post-baseline IOP measurement.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: An on-study AE were reported after the date of informed consent through the last study visit at Month 3. An AE was considered as treatment-emergent if the AE occurred on or after the treatment start date up to the last study visit. Treatment-emergent AEs were a subset of on-study AEs. AE reporting was executed until last study visit, 3 months later after randomization.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DE-117 Ophthalmic Solution	2 of 185 (1.1%)	74 of 185 (40%)	0 of 185
Latanoprost Ophthalmic Solution 0.005%	2 of 185 (1.1%)	55 of 185 (29.7%)	0 of 185

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Open Angle Glaucoma or Ocular Hypertension

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RecruitingPhase 1/2
REGN22530 for Adults With Primary Open Angle Glaucoma or Ocular Hypertension
Primary Open Angle Glaucoma (POAG), Ocular Hypertension (OHT)
RecruitingPhase 3
A Study to Evaluate Efficacy and Safety of YSBP Compared to Lumigan in Patients With Glaucoma or Ocular Hypertension
Primary Open Angle Glaucoma (POAG), Ocular Hypertension (OH)
RecruitingPhase 1/2
Safety and Efficacy of TimoD Sustained-Release Implant in Participants With Glaucoma or Ocular Hypertension Undergoing Cataract Surgery
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Active, not recruitingPhase 2
Evaluate Efficacy and Safety of PA5108 Ocular Implants in Primary Open Angle Glaucoma or Ocular Hypertension
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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 3 study testing DE-117 and Latanoprost ophthalmic solution in people with Open Angle Glaucoma or Ocular Hypertension, run by Santen Pharmaceutical Co., Ltd. at 1 site in Singapore.

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 15 Mar 2024. 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 Singapore. 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?

Yes. Results are posted in the registry (first posted 15 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Mean Diurnal IOP at Month 3 (time frame: Month 3 (average of IOP at 3 time points: 09:00, 13:00, 17:00)). 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 NCT02981446.

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 Mar 2024.