Primary Open-angle Glaucoma and Ocular HypertensionPhase 3NCT03697811

DE-117 Spectrum 5 Study

A Phase 3 study testing DE-117 Ophthalmic Solution in people with Primary Open-angle Glaucoma and Ocular Hypertension, run by Santen Inc. at 32 sites in United States.

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

Santen will evaluate the intraocular pressure (IOP) lowering effect and efficacy of DE-117 ophthalmic solution 0.002% in latanoprost low/non-responder subjects diagnosed with POAG or OHT Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Primary Open-angle Glaucoma and Ocular Hypertension
What is being tested?: DE-117 Ophthalmic Solution
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 107 participants
Where: 32 sitesUnited States
Study dates: 27 Sep 2018to 13 Jan 2022
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 Primary Open-Angle Glaucoma or Ocular Hypertension in one or both eyes.
Provide signed written informed consent.
Diagnosis of POAG or OHT in both eyes.
Qualifying corrected visual acuity in each eye.
Qualifying central corneal thickness in each eye.
Qualifying Day 1 IOP measurement at 3 time-points in both eyes after latanoprost Run-in Period.
Qualifying Anterior chamber angle.
Qualifying IOP measurement at 3 time-points during latanoprost Run-in Period.

Who cannot join

Patients who cannot safely discontinue use of Ocular Hypotensive Medications during Washout.
Patients with prior exposure to DE-117.
History of ocular surgery specifically intended to lower IOP
Advanced glaucoma in either eye.
Any corneal abnormality or other condition interfering with or preventing reliable Goldmann applanation tonometry.
Any ocular surgery or ocular laser treatment within 180 days prior to Visit 1 (Screening) and throughout the study in either eye.
Females who are pregnant, nursing, or planning a pregnancy.

Trial locations and contacts

32 sites in 1 country.

City, postcode or hospital

32 sites in 1 country

United States32 sites

Dixon Eye Care
Albany, Georgia, 31701-2363
Asheville Eye Associates, PLLC
Asheville, North Carolina, 28803
Texas Eye, PA
Austin, Texas, 78731
Arizona Eye Center
Chandler, Arizona, 85225
Mundorf Eye Center
Charlotte, North Carolina, 28204
Apex Eye Clinical Research, LLC
Cincinnati, Ohio, 45242
Abrams Eye Center
Cleveland, Ohio, 44115
Scott & Christie and Associates PC
Cranberry Township, Pennsylvania, 16066-6412
Danbury Eye Physicians & Surgeons
Danbury, Connecticut, 06810
Global Research Management
Glendale, California, 91204
Cornerstone Health Care
High Point, North Carolina, 27262
Shettle Eye Research, Inc.
Largo, Florida, 33773
Eye Clinic of Texas
League City, Texas, 77573
Total Eye Care PA
Memphis, Tennessee, 38119
VRF Eye Specialty Group
Memphis, Tennessee, 38120
North Valley Eye Medical Group
Mission Hills, California, 91345
Clayton Eye Clinical Research, LLC
Morrow, Georgia, 30260
Glaucoma Consultants and Center for Eye Research, PA
Mt. Pleasant, South Carolina, 29464
Nashville Vision Associates
Nashville, Tennessee, 37205
NYU Langone Health Department of Ophthalmology
New York, New York, 10017
Eye Research Foundation
Newport Beach, California, 92663
International Eye Associates, PA
Ormond Beach, Florida, 32174
North Bay Eye Associates
Petaluma, California, 94954
Martel Eye Medical Group
Rancho Cordova, California, 95670
Rochester Ophthalmological Group, PC
Rochester, New York, 14618
Coastal Research Associates, LEC
Roswell, Georgia, 30076
Medical Center Ophthalmology Associates
San Antonio, Texas, 78240
Heart of America Eye Care, P.A.
Shawnee Mission, Kansas, 66204
Tekwani Vision Center
St Louis, Missouri, 63128
The Eye Institute
Tulsa, Oklahoma, 74104
South Shore Eye Center
Wantagh, New York, 14618
Comprehensive Eye Care Ltd
Washington, Missouri, 63090

Other trials in United States

About this study

Official title: An Open-Label, Multicenter Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution 0.002% in Latanoprost Low/Non-Responder Subjects Diagnosed With Primary Open-Angle Glaucoma or Ocular Hypertension - Spectrum 5 Study

Santen will evaluate the intraocular pressure (IOP) lowering effect and efficacy of DE-117 ophthalmic solution 0.002% in latanoprost low/non-responder subjects diagnosed with POAG or OHT

Conditions: Primary Open-angle Glaucoma and Ocular Hypertension
Being tested: DE-117 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-117 Ophthalmic SolutionDrug
Interventional treatment will be made with DE-117 Ophthalmic Solution 0.002% once daily in the evening for the duration of the 3 month treatment period.

Study groups in NCT03697811
Study group	Role	What they receive
DE-117 Ophthalmic Solution 0.002%	Experimental	Interventional treatment will be made with DE-117 Ophthalmic Solution 0.002% once daily in the evening for the duration of the 3 month treatment period. Receives: Drug: DE-117 Ophthalmic Solution

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 (IOP) at Month 3.
IOP lowering effect of DE-117 ophthalmic solution 0.002% in Latanoprost low/non-responder subjects. Mean Diurnal Intraocular Pressure: Analysis of Change from Baseline in IOP score at Month 3 using Paired T-test on Observed Case. Mean Diurnal IOP is defined as the average IOP of all three timepoints (8:00,12:00, 16:00) at Month 3.
Measured: Month 3

Secondary outcomes (8)

Percent Change From Baseline in Mean Diurnal IOP at Week 2, Week 6 and Month 3
The secondary efficacy endpoint evaluated percent change from baseline in mean DIOP at week 2, 6 and month 3.
Measured: week 2, 6 and month 3
Change From Baseline in Mean Diurnal IOP at Week 2 and Week 6
Change from baseline (Visit 4) in mean diurnal IOP at Week 2 (Visit 5) and Week 6 (Visit 6).
Measured: week 2 and 6
Change From Baseline in IOP at Timepoints at Week 2
Change in mean IOP were evaluated at each time point at all post-baseline visits. (Change from baseline measurement at each timepoint was calculated by deducting the baseline value at corresponding timepoint from the IOP measurement).
Measured: 08:00, 12:00 and 16:00 at Week 2
Change From Baseline in IOP at Timepoints at Week 6
Change in mean IOP were evaluated at each time point at all post-baseline visits.
Measured: 08:00, 12:00 and 16:00 at Week 6
Change From Baseline in IOP at Timepoints at Month 3
Change in mean IOP were evaluated at each time point at all post-baseline visits.
Measured: 08:00, 12:00 and 16:00 at month 3
Intraocular Pressure: Percent Change From Baseline by Analysis Visit and Timepoint at Week 2
Intraocular Pressure: Percent Change from Baseline by Analysis Visit and Timepoint.
Measured: 08:00, 12:00 and 16:00 at week 2
Intraocular Pressure: Percent Change From Baseline by Analysis Visit and Timepoint at Week 6
Intraocular Pressure: Percent Change from Baseline by Analysis Visit and Timepoint.
Measured: 08:00, 12:00 and 16:00 at week 6
Intraocular Pressure: Percent Change From Baseline by Analysis Visit and Timepoint at Month 3
Intraocular Pressure: Percent Change from Baseline by Analysis Visit and Timepoint.
Measured: 08:00, 12:00 and 16:00 at month 3.

Timeline

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

27 Sep 201813 Jan 2022

First posted5 Oct 2018
Study start27 Sep 2018
Primary completion13 Jan 2022
Study completion13 Jan 2022

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Primary Open-angle Glaucoma and 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 107 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03697811
Sponsor's protocol ID: 011711IN
Status last verified: Aug 2023
First submitted: 3 Oct 2018
Last updated: 30 Aug 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Panarelli JF, Bowden EC, Tepedino ME, Odani-Kawabata N, Pei Z, McLaurin EB, Ropo A. Omidenepag Isopropyl in Latanoprost Low/Nonresponders With Primary Open Angle Glaucoma or Ocular Hypertension: A Phase 3, Nonrandomized, Two-Phase, Open-Label Study. J Glaucoma. 2023 Dec 1;32(12):999-1005. doi: 10.1097/IJG.0000000000002321. Epub 2023 Oct 17.
PubMed 37853676

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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All Primary Open-angle Glaucoma and Ocular Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Multicenter Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution 0.002% in Latanoprost Low/Non-Responder Subjects Diagnosed With Primary Open-Angle Glaucoma or Ocular Hypertension - Spectrum 5 Study
ClinicalTrials.gov ID: NCT03697811
Acronym / sponsor ID: 011711IN
Conditions: Primary Open-angle Glaucoma and Ocular Hypertension
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 107 participants (actual)
Lead sponsor: Santen Inc.Industry (pharma, biotech, devices)
Study start: 27 Sep 2018 (actual)
Primary completion: 13 Jan 2022 (actual)
Study completion: 13 Jan 2022 (actual)
First posted: 5 Oct 2018 (actual)
Results: Posted 30 Aug 2023

Clinical summary

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

Santen will evaluate the intraocular pressure (IOP) lowering effect and efficacy of DE-117 ophthalmic solution 0.002% in latanoprost low/non-responder subjects diagnosed with POAG or OHT

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
DE-117 Ophthalmic Solution 0.002%	Experimental	Drug: DE-117 Ophthalmic SolutionInterventional treatment will be made with DE-117 Ophthalmic Solution 0.002% once daily in the evening for the duration of the 3 month treatment period.

Who may qualify

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

Key inclusion criteria (8 listed)

Patients with Primary Open-Angle Glaucoma or Ocular Hypertension in one or both eyes.
Provide signed written informed consent.
Diagnosis of POAG or OHT in both eyes.
Qualifying corrected visual acuity in each eye.
Qualifying central corneal thickness in each eye.

Key exclusion criteria (7 listed)

Patients who cannot safely discontinue use of Ocular Hypotensive Medications during Washout.
Patients with prior exposure to DE-117.
History of ocular surgery specifically intended to lower IOP
Advanced glaucoma in either eye.
Any corneal abnormality or other condition interfering with or preventing reliable Goldmann applanation tonometry.

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-117 Ophthalmic SolutionInterventional treatment will be made with DE-117 Ophthalmic Solution 0.002% once daily in the evening for the duration of the 3 month treatment period.	Drug	DE-117 Ophthalmic Solution 0.002%

Primary outcome

Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Month 3.
Time frame: Month 3
IOP lowering effect of DE-117 ophthalmic solution 0.002% in Latanoprost low/non-responder subjects. Mean Diurnal Intraocular Pressure: Analysis of Change from Baseline in IOP score at Month 3 using Paired T-test on Observed Case. Mean Diurnal IOP is defined as the average IOP of all three timepoints (8:00,12:00, 16:00) at Month 3.

8 secondary outcomes

Percent Change From Baseline in Mean Diurnal IOP at Week 2, Week 6 and Month 3
Time frame: week 2, 6 and month 3
Change From Baseline in Mean Diurnal IOP at Week 2 and Week 6
Time frame: week 2 and 6
Change From Baseline in IOP at Timepoints at Week 2
Time frame: 08:00, 12:00 and 16:00 at Week 2
Change From Baseline in IOP at Timepoints at Week 6
Time frame: 08:00, 12:00 and 16:00 at Week 6
Change From Baseline in IOP at Timepoints at Month 3
Time frame: 08:00, 12:00 and 16:00 at month 3
Intraocular Pressure: Percent Change From Baseline by Analysis Visit and Timepoint at Week 2
Time frame: 08:00, 12:00 and 16:00 at week 2
Intraocular Pressure: Percent Change From Baseline by Analysis Visit and Timepoint at Week 6
Time frame: 08:00, 12:00 and 16:00 at week 6
Intraocular Pressure: Percent Change From Baseline by Analysis Visit and Timepoint at Month 3
Time frame: 08:00, 12:00 and 16:00 at month 3.

Results and safety

Results posted to the registry on 30 Aug 2023, 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 0.002%	107	104

Primary outcome: Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Month 3.

Time frame: Month 3. Mean (Standard Deviation). Unit: mmHg

Measure	DE-117 Ophthalmic Solution 0.002% n = 102
Value	-2.96 (2.831)

Population analysed: Full Analysis Set (observed cases only)

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events in this study were collected from the time of informed consent and were followed to resolution, or until the subject's participation in the study ended at Month 3.. Other adverse events reported at 1.0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DE-117 Ophthalmic Solution 0.002%	0 of 107 (0%)	27 of 107 (25.2%)	0 of 107

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37853676Panarelli JF, Bowden EC, Tepedino ME, Odani-Kawabata N, Pei Z, McLaurin EB, Ropo A. Omidenepag Isopropyl in Latanoprost Low/Nonresponders With Primary Open Angle Glaucoma or Ocular Hypertension: A Phase 3, Nonrandomized, Two-Phase, Open-Label Study. J Glaucoma. 2023 Dec 1;32(12):999-1005. doi: 10.1097/IJG.0000000000002321. Epub 2023 Oct 17.

Related trials for Primary Open-angle Glaucoma and 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.

32 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 DE-117 Ophthalmic Solution in people with Primary Open-angle Glaucoma and Ocular Hypertension, run by Santen Inc. at 32 sites in United States.

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 8 inclusion and 7 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 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in United States. 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 30 Aug 2023). 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?

Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Month 3. (time frame: Month 3). 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 NCT03697811, 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 30 Aug 2023.