Glaucoma and Ocular HypertensionPhase 3NCT03691662

A Phase III Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Glaucoma or Ocular Hypertension - Spectrum 4 Study

A Phase 3 study testing DE-117 Ophthalmic Solution and Timolol Maleate Ophthalmic Solution 0.5% in people with Glaucoma and Ocular Hypertension, run by Santen Inc. at 34 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 12 months and older
Conditions the study is for: Glaucoma and Ocular Hypertension
What is being tested?: DE-117 Ophthalmic Solution and Timolol Maleate Ophthalmic Solution 0.5%
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 417 participants
Where: 34 sitesUnited States
Study dates: 27 Sep 2018to 23 Oct 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 12 months and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

glaucoma or ocular hypertension

Who cannot join

Females who are pregnant, nursing, or planning a pregnancy
Any corneal abnormality or other condition interfering with or preventing reliable tonometric measurements

Trial locations and contacts

34 sites in 1 country.

City, postcode or hospital

34 sites in 1 country

United States34 sites

Asheville Eye Associates
Asheville, North Carolina, 28803-2493
Arizona Eye Center
Chandler, Arizona, 85224
Abrams Eye Center
Cleveland, Ohio, 44115
Haas Vision Center
Colorado Springs, Colorado, 80919-5913
Glaucoma Associates of Texas
Dallas, Texas, 75231-2168
Florida Ophthalmic Institute
Gainesville, Florida, 32605-3192
Global Research Management
Glendale, California, 91204
Seidenberg Protzko Eye Associates
Havre de Grace, Maryland, 21078
Houston Eye Associates HEA - Gramercy Location
Houston, Texas, 77025-1756
Baylor College of Medicine Alkek Eye Center
Houston, Texas, 77030
Discover Vision Centers
Independence, Missouri, 64055-6974
United Medical Research Inst
Inglewood, California, 90301
Silverstein Eye Centers
Kansas City, Missouri, 64133
St. Michaels Eye Laser Institute
Largo, Florida, 33770-3225
AdvanceMed Clinical Research
Las Vegas, Nevada, 89123
The Eye Clinic of Texas
League City, Texas, 77573-5148
Total Eye Care PA
Memphis, Tennessee, 38119-5770
VRF Eye Specialty Group
Memphis, Tennessee, 38120
Clayton Eye Clinical Research, LLC
Morrow, Georgia, 30260
Eye Research Foundation
Newport Beach, California, 92663-3642
International Eye Associates PA
Ormond Beach, Florida, 32174
North Bay Eye Associates Inc.
Petaluma, California, 94954-2387
M & M Eye Institute
Prescott, Arizona, 86301-6610
Vistar Eye Center
Roanoke, Virginia, 24016-5100
Rochester Ophthalmological Group, PC
Rochester, New York, 14618
Sacramento Eye Consultants
Sacramento, California, 95815-4605
Great Lakes Eye Care P.C
Saint Joseph, Michigan, 49085
Stacy R. Smith M.D. P.C.
Salt Lake City, Utah, 84117
Medical Center Ophthalmology Associates
San Antonio, Texas, 78240-1502
AdvanceMed Clinical Research
San Diego, California, 92122
East Florida Eye Institute
Stuart, Florida, 34994
Tidewater Clinical Research
Virginia Beach, Virginia, 23456
Comprehensive Eye Care Ltd.
Washington, Missouri, 63090-3010
Michael K. Tran, MD, Inc.
Westminster, California, 92683-7071

Other trials in United States

About this study

Official title: A Phase III, Randomized, Double-Masked, Active-Controlled, Parallel-Group, Multicenter Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Glaucoma or Ocular Hypertension - Spectrum 4 Study

This is a Phase III, randomized, double-masked, active-controlled, parallel-group, multi-center study. Subjects diagnosed with glaucoma or OHT who meet eligibility criteria at Visit 1 (Screening) will washout of 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 baseline will be randomized to receive double-masked treatment for 3 months.

Approximately 400 adult subjects and up to 30 pediatric subjects with glaucoma or OHT who meet all eligibility criteria will be randomized in a 1:1 ratio to receive either:

DE-117 Ophthalmic Solution once daily and Vehicle once daily, or
Timolol Maleate Ophthalmic Solution 0.5% twice daily. The study will evaluate the efficacy and safety of DE-117 Ophthalmic Solution compared with Timolol Maleate Ophthalmic Solution 0.5% in subjects with glaucoma or OHT through Month 3.

Conditions: Glaucoma and Ocular Hypertension
Being tested: DE-117 Ophthalmic Solution, Timolol Maleate Ophthalmic Solution 0.5%
Medical subject headings: Glaucoma, 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
Topical DE-117 Ophthalmic Solution once daily and Vehicle once daily for 3 months
Timolol Maleate Ophthalmic Solution 0.5%Drug
Topical Timolol Maleate Ophthalmic Solution 0.5% twice daily for 3 months

Study groups in NCT03691662
Study group	Role	What they receive
DE-117 Ophthalmic Solution	Experimental	Topical DE-117 Ophthalmic Solution once daily and Vehicle once daily for 3 months Receives: Drug: DE-117 Ophthalmic Solution
Timolol Maleate Ophthalmic Solution 0.5%	Active comparator	Topical Timolol Maleate Ophthalmic Solution 0.5% twice daily for 3 months Receives: Drug: Timolol Maleate Ophthalmic Solution 0.5%

What is being measured

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

Intraocular Pressure (IOP) at Week 1
Intraocular Pressure: Analysis of IOP Score using Mixed Model for Repeated Measures (MMRM) on Observed Cases (Study Eye, Full Analysis Set). Intraocular Pressure (IOP), the fluid pressure inside the eye was measured with calibrated Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time points throughout the day.
Measured: 08:00, 10:00 and 16:00 at Week 1
Intraocular Pressure (IOP) at Week 6
Intraocular Pressure: Analysis of IOP Score using Mixed Model for Repeated Measures (MMRM) on Observed Cases (Study Eye, Full Analysis Set). Intraocular Pressure (IOP), the fluid pressure inside the eye was measured with calibrated Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time points throughout the day.
Measured: 08:00, 10:00 and 16:00 at Week 6
Intraocular Pressure (IOP) at Month 3
Intraocular Pressure: Analysis of IOP Score using Mixed Model for Repeated Measures (MMRM) on Observed Cases (Study Eye, Full Analysis Set). Intraocular Pressure (IOP), the fluid pressure inside the eye was measured with calibrated Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time points throughout the day.
Measured: 08:00, 10:00 and 16:00 at Month 3

Secondary outcomes (5)

Mean Diurnal Intraocular Pressure (IOP) at Month 3 (First Key Secondary Endpoint)
To determine if the mean diurnal IOP reduction with DE-117 ophthalmic solution 0.002% is superior to that of Timolol Maleate ophthalmic solution 0.5% at Month 3 in subjects with OAG or OHT. Mean Diurnal IOP is defined as the average IOP of all three timepoints (8AM, 10AM and 4PM) at Month 3.
Measured: Month 3
Intraocular Pressure (IOP) at Week 1 With Baseline Mean Diurnal IOP Less Than 25 mmHg (Second Key Secondary Endpoint)
Intraocular Pressure (IOP) at Week 1 with baseline mean diurnal IOP less than 25 mmHg (Second Key Secondary Endpoint)
Measured: 08:00, 10:00 and 16:00 at week 1
Intraocular Pressure (IOP) at Week 6 With Baseline Mean Diurnal IOP Less Than 25 mmHg (Second Key Secondary Endpoint)
Intraocular Pressure (IOP) at Week 6 with baseline mean diurnal IOP less than 25 mmHg (Second Key Secondary Endpoint)
Measured: 08:00, 10:00 and 16:00 at week 6
Intraocular Pressure (IOP) at Month 3 With Baseline Mean Diurnal IOP Less Than 25 mmHg (Second Key Secondary Endpoint)
Intraocular Pressure (IOP) at Month 3 with baseline mean diurnal IOP less than 25 mmHg (Second Key Secondary Endpoint)
Measured: 08:00, 10:00 and 16:00 at month 3
Mean Diurnal Intraocular Pressure (IOP) at Week 1 (Third Key Secondary Endpoint)
The third key secondary endpoint, mean diurnal IOP at Week 1, the hypothesis of superiority of DE-117 to timolol was tested. Analysis using MMRM on Observed Cases.
Mean Diurnal IOP is defined as the average IOP of all three timepoints (8AM, 10AM and 4PM) at week 1.
Measured: week 1

Timeline

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

27 Sep 201823 Oct 2019

First posted2 Oct 2018
Study start27 Sep 2018
Primary completion23 Oct 2019
Study completion23 Oct 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 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: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 417 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03691662
Sponsor's protocol ID: 011710IN
Status last verified: Aug 2023
First submitted: 28 Sep 2018
Last updated: 9 Aug 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
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

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Study at a glance

From the registry record, last updated by the sponsor on 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Randomized, Double-Masked, Active-Controlled, Parallel-Group, Multicenter Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Glaucoma or Ocular Hypertension - Spectrum 4 Study
ClinicalTrials.gov ID: NCT03691662
Acronym / sponsor ID: 011710IN
Conditions: Glaucoma and Ocular Hypertension
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 417 participants (actual)
Lead sponsor: Santen Inc.Industry (pharma, biotech, devices)
Study start: 27 Sep 2018 (actual)
Primary completion: 23 Oct 2019 (actual)
Study completion: 23 Oct 2019 (actual)
First posted: 2 Oct 2018 (actual)
Results: Posted 9 Aug 2023

Clinical summary

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

Approximately 400 adult subjects and up to 30 pediatric subjects with glaucoma or OHT who meet all eligibility criteria will be randomized in a 1:1 ratio to receive either:

DE-117 Ophthalmic Solution once daily and Vehicle once daily, or
Timolol Maleate Ophthalmic Solution 0.5% twice daily. The study will evaluate the efficacy and safety of DE-117 Ophthalmic Solution compared with Timolol Maleate Ophthalmic Solution 0.5% in subjects with glaucoma or OHT through Month 3.

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
DE-117 Ophthalmic Solution	Experimental	Drug: DE-117 Ophthalmic SolutionTopical DE-117 Ophthalmic Solution once daily and Vehicle once daily for 3 months
Timolol Maleate Ophthalmic Solution 0.5%	Active comparator	Drug: Timolol Maleate Ophthalmic Solution 0.5%Topical Timolol Maleate Ophthalmic Solution 0.5% twice daily for 3 months

Who may qualify

Ages: 12 months and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

glaucoma or ocular hypertension

Key exclusion criteria (2 listed)

Females who are pregnant, nursing, or planning a pregnancy
Any corneal abnormality or other condition interfering with or preventing reliable tonometric measurements

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 SolutionTopical DE-117 Ophthalmic Solution once daily and Vehicle once daily for 3 months	Drug	DE-117 Ophthalmic Solution
Timolol Maleate Ophthalmic Solution 0.5%Topical Timolol Maleate Ophthalmic Solution 0.5% twice daily for 3 months	Drug	Timolol Maleate Ophthalmic Solution 0.5%

Primary outcome

Intraocular Pressure (IOP) at Week 1
Time frame: 08:00, 10:00 and 16:00 at Week 1
Intraocular Pressure: Analysis of IOP Score using Mixed Model for Repeated Measures (MMRM) on Observed Cases (Study Eye, Full Analysis Set). Intraocular Pressure (IOP), the fluid pressure inside the eye was measured with calibrated Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time points throughout the day.
Intraocular Pressure (IOP) at Week 6
Time frame: 08:00, 10:00 and 16:00 at Week 6
Intraocular Pressure: Analysis of IOP Score using Mixed Model for Repeated Measures (MMRM) on Observed Cases (Study Eye, Full Analysis Set). Intraocular Pressure (IOP), the fluid pressure inside the eye was measured with calibrated Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time points throughout the day.
Intraocular Pressure (IOP) at Month 3
Time frame: 08:00, 10:00 and 16:00 at Month 3
Intraocular Pressure: Analysis of IOP Score using Mixed Model for Repeated Measures (MMRM) on Observed Cases (Study Eye, Full Analysis Set). Intraocular Pressure (IOP), the fluid pressure inside the eye was measured with calibrated Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time points throughout the day.

5 secondary outcomes

Mean Diurnal Intraocular Pressure (IOP) at Month 3 (First Key Secondary Endpoint)
Time frame: Month 3
Intraocular Pressure (IOP) at Week 1 With Baseline Mean Diurnal IOP Less Than 25 mmHg (Second Key Secondary Endpoint)
Time frame: 08:00, 10:00 and 16:00 at week 1
Intraocular Pressure (IOP) at Week 6 With Baseline Mean Diurnal IOP Less Than 25 mmHg (Second Key Secondary Endpoint)
Time frame: 08:00, 10:00 and 16:00 at week 6
Intraocular Pressure (IOP) at Month 3 With Baseline Mean Diurnal IOP Less Than 25 mmHg (Second Key Secondary Endpoint)
Time frame: 08:00, 10:00 and 16:00 at month 3
Mean Diurnal Intraocular Pressure (IOP) at Week 1 (Third Key Secondary Endpoint)
Time frame: week 1

Results and safety

Results posted to the registry on 9 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% QD (20:00) and Vehicle QD (08:00)	208	187
Timolol Maleate Ophthalmic Solution 0.5% BID (20:00 & 08:00)	209	196

Primary outcome: Intraocular Pressure (IOP) at Week 1

Time frame: 08:00, 10:00 and 16:00 at Week 1. Least squares mean (Standard Error). Unit: mmHg

Measure	DE-117 Ophthalmic Solution 0.002% QD (20:00) and Vehicle QD (08:00) n = 204	Timolol Maleate Ophthalmic Solution 0.5% BID (20:00 & 08:00) n = 205
8:00	19.4 (0.23)	19.7 (0.23)
10:00	18.5 (0.22)	18.9 (0.22)
16:00	17.9 (0.23)	18.6 (0.22)

Population analysed: Full Analysis Set (FAS) included all randomized subjects who received at least one dose of study medication and provided baseline and at least one post-baseline IOP measurement. The number of analyzed are participants evaluable for the outcome measure at Week 1.

Primary outcome: Intraocular Pressure (IOP) at Week 6

Time frame: 08:00, 10:00 and 16:00 at Week 6. Least squares mean (Standard Error). Unit: mmHg

Measure	DE-117 Ophthalmic Solution 0.002% QD (20:00) and Vehicle QD (08:00) n = 204	Timolol Maleate Ophthalmic Solution 0.5% BID (20:00 & 08:00) n = 205
8:00	20.4 (0.22)	19.5 (0.21)
10:00	19.5 (0.20)	18.8 (0.20)
16:00	19.2 (0.21)	18.8 (0.21)

Primary outcome: Intraocular Pressure (IOP) at Month 3

Time frame: 08:00, 10:00 and 16:00 at Month 3. Least squares mean (Standard Error). Unit: mmHg

Measure	DE-117 Ophthalmic Solution 0.002% QD (20:00) and Vehicle QD (08:00) n = 204	Timolol Maleate Ophthalmic Solution 0.5% BID (20:00 & 08:00) n = 205
8:00	20.0 (0.22)	19.6 (0.22)
10:00	19.4 (0.23)	18.9 (0.22)
16:00	19.1 (0.23)	19.0 (0.22)

5 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	7 of 204 (3.4%)	68 of 204 (33.3%)	1 of 204
Timolol Maleate Ophthalmic Solution 0.5%	1 of 205 (0.5%)	49 of 205 (23.9%)	0 of 205

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

34 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 and Timolol Maleate Ophthalmic Solution 0.5% in people with Glaucoma and Ocular Hypertension, run by Santen Inc. at 34 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 1 inclusion and 2 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 9 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 34 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 9 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?

Intraocular Pressure (IOP) at Week 1 (time frame: 08:00, 10:00 and 16:00 at Week 1). The study lists 3 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 NCT03691662.

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 9 Aug 2023.