Primary Open-angle Glaucoma and Ocular HypertensionPhase 2NCT03858894

Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution Once Daily and Twice Daily in Subjects With Primary Open-Angle Glaucoma SPECTRUM 6

A Phase 2 study testing DE-117 Ophthalmic Solution QD and DE-117 Ophthalmic Solution BID in people with Primary Open-angle Glaucoma and Ocular Hypertension, run by Santen Inc. at 13 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

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 QD and DE-117 Ophthalmic Solution BID
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 98 participants
Where: 13 sitesUnited States
Study dates: 28 Jan 2019to 20 Jun 2019
Phase: Phase 2
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

Provide signed written informed consent
Have a diagnosis of POAG or OHT in both eyes, or one eye with POAG and the other with OHT.
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
Qualifying Anterior chamber angle

Who cannot join

History of ocular surgery specifically intended to lower IOP
Subjects who cannot safely discontinue use of ocular hypotensive medications during the wait/washout period
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 Screening and throughout the study in either eye
Females who are pregnant, nursing, or planning a pregnancy

Trial locations and contacts

13 sites in 1 country.

City, postcode or hospital

13 sites in 1 country

United States13 sites

Hernando Eye Institute
Brooksville, Florida, 34613
Apex Eye Clinical Research, LLC
Cincinnati, Ohio, 45242
Abrams Eye Center
Cleveland, Ohio, 44115
Scott & Christie and Associates PC
Cranberry Township, Pennsylvania, 16066
Danbury Eye Specialist
Danbury, Connecticut, 06810
Seidenberg Protzko Eye Associates
Havre de Grace, Maryland, 21078
Levenson Eye Associates
Jacksonville, Florida, 32204
East West Eye Institute
Los Angeles, California, 90013
Ophthalmic Consultants of Long Island
Lynbrook, New York, 11563
University Eye Specialist
Maryville, Tennessee, 37803
Advanced Vision Research
Nashville, Tennessee, 37205
Tekwani Vision Center
St Louis, Missouri, 63128
Eye Associates/SurgiCenter of Vineland
Vineland, New Jersey, 08361

Other trials in United States

About this study

Official title: A Randomized, Double-Masked, Parallel-Group, Multicenter Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution 0.002% Once Daily and Twice Daily in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension SPECTRUM 6 Study.

This is a randomized, double-masked, parallel-group, multi-center study. Subjects diagnosed with POAG or OHT who meet eligibility criteria at Visit 1 (Screening) will wash out their current topical IOP lowering medication(s), if any. After completing the required washout period, subjects will return for Visit 2 (Baseline, Day 1). Subjects who meet all eligibility criteria at Visit 2 (Baseline, Day 1) will be randomized to receive study medication for up to 6 weeks.

Approximately 100 subjects with POAG or OHT will be randomized in a 1:1 ratio to either:

DE-117 ophthalmic solution 0.002% QD (Once Daily)
DE-117 ophthalmic solution 0.002% BID (Twice Daily)

This study will consist of a screening period of up to 35 days including a washout period of up to 28 days (+ 7 days window), and a 6-week double-masked treatment period.

Conditions: Primary Open-angle Glaucoma and Ocular Hypertension
Being tested: DE-117 Ophthalmic Solution QD, DE-117 Ophthalmic Solution BID
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 Solution QDDrug
DE-117 ophthalmic solution QD and Vehicle (no active DE-117 ingredient) QD add one drop in each eye
DE-117 Ophthalmic Solution BIDDrug
DE-117 ophthalmic solution BID twice Daily (20:00 and 8:00) add one drop in each eye

Study groups in NCT03858894
Study group	Role	What they receive
Drug Arm: DE-117 QD	Experimental	DE-117 Ophthalmic Solution QD (20:00) and Vehicle (8:00; no active DE-117 ingredient) QD Receives: Drug: DE-117 Ophthalmic Solution QD
Test Arm: DE-117 BID	Experimental	DE-117 Ophthalmic Solution BID Twice daily (20:00 and 8:00) Receives: Drug: DE-117 Ophthalmic Solution BID

What is being measured

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

Intraocular Pressure (IOP) at Week 2
Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg).
Measured: 08:00 at week 2
Intraocular Pressure (IOP) at Week 2
Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg).
Measured: 12:00 at week 2
Intraocular Pressure (IOP) at Week 2
Intraocular pressure (IOP), the fluid pressure inside the eye, was mea...
Measured: 16:00 at week 2
Intraocular Pressure (IOP) at Week 6
Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg).
Measured: 08:00 at week 6
Intraocular Pressure (IOP) at Week 6
Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg).
Measured: 12:00 at week 6
Intraocular Pressure (IOP) at Week 6
Intraocular pressure (IOP), the fluid pressure inside the eye, was mea...
Measured: 16:00 at week 6

Secondary outcomes (1)

Mean Diurnal Intraocular Pressure (IOP)
Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg).
Measured: 6 weeks

Timeline

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

28 Jan 201920 Jun 2019

First posted1 Mar 2019
Study start28 Jan 2019
Primary completion20 Jun 2019
Study completion20 Jun 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 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 98 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03858894
Sponsor's protocol ID: 011712IN
Status last verified: Jul 2020
First submitted: 27 Feb 2019
Last updated: 4 Aug 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: 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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Study at a glance

From the registry record, last updated by the sponsor on 4 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Masked, Parallel-Group, Multicenter Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution 0.002% Once Daily and Twice Daily in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension SPECTRUM 6 Study.
ClinicalTrials.gov ID: NCT03858894
Acronym / sponsor ID: 011712IN
Conditions: Primary Open-angle Glaucoma and Ocular Hypertension
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 98 participants (actual)
Lead sponsor: Santen Inc.Industry (pharma, biotech, devices)
Study start: 28 Jan 2019 (actual)
Primary completion: 20 Jun 2019 (actual)
Study completion: 20 Jun 2019 (actual)
First posted: 1 Mar 2019 (actual)
Results: Posted 4 Aug 2020

Clinical summary

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

Approximately 100 subjects with POAG or OHT will be randomized in a 1:1 ratio to either:

DE-117 ophthalmic solution 0.002% QD (Once Daily)
DE-117 ophthalmic solution 0.002% BID (Twice Daily)

This study will consist of a screening period of up to 35 days including a washout period of up to 28 days (+ 7 days window), and a 6-week double-masked treatment period.

Study design

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

Arm	Type	Receives
Drug Arm: DE-117 QD	Experimental	Drug: DE-117 Ophthalmic Solution QDDE-117 Ophthalmic Solution QD (20:00) and Vehicle (8:00; no active DE-117 ingredient) QD
Test Arm: DE-117 BID	Experimental	Drug: DE-117 Ophthalmic Solution BIDDE-117 Ophthalmic Solution BID Twice daily (20:00 and 8:00)

Who may qualify

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

Key inclusion criteria (6 listed)

Provide signed written informed consent
Have a diagnosis of POAG or OHT in both eyes, or one eye with POAG and the other with OHT.
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

Key exclusion criteria (6 listed)

History of ocular surgery specifically intended to lower IOP
Subjects who cannot safely discontinue use of ocular hypotensive medications during the wait/washout period
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 Screening and throughout the study 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
DE-117 Ophthalmic Solution QDDE-117 ophthalmic solution QD and Vehicle (no active DE-117 ingredient) QD add one drop in each eye	Drug	Drug Arm: DE-117 QD
DE-117 Ophthalmic Solution BIDDE-117 ophthalmic solution BID twice Daily (20:00 and 8:00) add one drop in each eye	Drug	Test Arm: DE-117 BID

Primary outcome

Intraocular Pressure (IOP) at Week 2
Time frame: 08:00 at week 2
Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg).
Intraocular Pressure (IOP) at Week 2
Time frame: 12:00 at week 2
Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg).
Intraocular Pressure (IOP) at Week 2
Time frame: 16:00 at week 2
Intraocular pressure (IOP), the fluid pressure inside the eye, was mea...
Intraocular Pressure (IOP) at Week 6
Time frame: 08:00 at week 6
Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg).
Intraocular Pressure (IOP) at Week 6
Time frame: 12:00 at week 6
Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg).
Intraocular Pressure (IOP) at Week 6
Time frame: 16:00 at week 6
Intraocular pressure (IOP), the fluid pressure inside the eye, was mea...

1 secondary outcome

Mean Diurnal Intraocular Pressure (IOP)
Time frame: 6 weeks

Results and safety

Results posted to the registry on 4 Aug 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Test Arm: DE-117 BID	48	44
Drug Arm: DE-117 QD	50	50

Primary outcome: Intraocular Pressure (IOP) at Week 2

Time frame: 08:00 at week 2. Least squares mean (Standard Error). Unit: mmHg

Measure	Test Arm: DE-117 BID n = 48	Drug Arm: DE-117 QD n = 50
Value	18.19 (0.46)	19.15 (0.45)

Primary outcome: Intraocular Pressure (IOP) at Week 2

Time frame: 12:00 at week 2. Least squares mean (Standard Error). Unit: mmHg

Measure	Test Arm: DE-117 BID n = 48	Drug Arm: DE-117 QD n = 50
Value	17.73 (0.49)	18.17 (0.46)

Primary outcome: Intraocular Pressure (IOP) at Week 2

Time frame: 16:00 at week 2. Least squares mean (Standard Error). Unit: mmHg

Measure	Test Arm: DE-117 BID n = 48	Drug Arm: DE-117 QD n = 50
Value	16.73 (0.47)	17.81 (0.44)

Primary outcome: Intraocular Pressure (IOP) at Week 6

Time frame: 08:00 at week 6. Least squares mean (Standard Error). Unit: mmHg

Measure	Test Arm: DE-117 BID n = 48	Drug Arm: DE-117 QD n = 50
Value	18.33 (0.49)	19.01 (0.47)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: All SAEs were collected from the signing of the Inform Consent Form until the subject withdrew or completed the scheduled exit visit at Week 6.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Test Arm: DE-117 BID	0 of 48 (0%)	20 of 48 (41.7%)	0 of 48
Drug Arm: DE-117 QD	1 of 50 (2%)	7 of 50 (14%)	0 of 50

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

13 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 6 inclusion and 6 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 4 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 4 Aug 2020). 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?

Intraocular Pressure (IOP) at Week 2 (time frame: 08:00 at week 2). The study lists 6 primary outcomes in all. 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 NCT03858894.

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 4 Aug 2020; AzTrials last refreshed its copy on 7 Nov 2026.