Glaucoma and Ocular HypertensionPhase 3NCT03691649
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 3 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 47 sites in United States.
Trial summary
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. Read more about this study
- 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
- 426 participants
- Where
- 47 sitesUnited States
- Study dates
- 14 Sep 2018to 3 Sep 2020
- 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
47 sites in 1 country.
47 sites in 1 country
United States47 sites
Dixophthal PC Dba. Dixon Eye Care
Albany, Georgia, 31701-2363
Coastal Research Associates
Alpharetta, Georgia, 30076
Asheville Eye Associates
Asheville, North Carolina, 28803-2493
Keystone Research Ltd. Texan Eye PA
Austin, Texas, 78731-4203
Specialty Eye Care Centre
Bellevue, Washington, 98004
Indiana University
Bloomington, Indiana, 47405
Hernando Eye Institute
Brooksville, Florida, 34613-6065
Havana Research Institute
Burbank, California, 91506
Charlotte Eye Ear Nose & Throat Associates, PA
Charlotte, North Carolina, 28210
Apex Eye Clinical Research, LLC
Cincinnati, Ohio, 45242
MCB Clinical Research Centers LLC
Colorado Springs, Colorado, 80909
Ophthalmic Surgeons & Consultants of Ohio, Inc.
Columbus, Ohio, 43215
Scott & Christie and Associates PC
Cranberry Township, Pennsylvania, 16066
The Cataract and Glaucoma Center
El Paso, Texas, 79902
Emerson Clinical Research Institute
Falls Church, Virginia, 22046
Eye Associates of Fort Myers
Fort Myers, Florida, 33901-9311
Ophthalmology Associates
Fort Worth, Texas, 76102
Cornerstone Eye Care
High Point, North Carolina, 27262
Bowden Eye & Associates
Jacksonville, Florida, 32256
Tauber Eye Center
Kansas City, Missouri, 64111
Shettle Eye Research
Largo, Florida, 33773
Nevada Eye Care Professionals
Las Vegas, Nevada, 89119
Wellish Vision Institute
Las Vegas, Nevada, 89119
AdvanceMed Clinical Research-Las Vegas
Las Vegas, Nevada, 89123-2810
Macy Eye Center
Los Angeles, California, 90048-6149
University Eye Specialists
Maryville, Tennessee, 37803
Total Eye Care PA
Memphis, Tennessee, 38119-5770
Shah Research LLC dba Discovery Clinical Trials
Mission, Texas, 78572-2425
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, 29464-8298
NY Eye & ear Infirmary of Mt Sinai (NYEE)
New York, New York, 10003
North Bay Eye Associates, Inc
Petaluma, California, 94954
Arizona Glaucoma Specialists
Phoenix, Arizona, 85050
Martel Eye Medical Group
Rancho Cordova, California, 95670
Black Hills Regional Eye Institute, LLP
Rapid City, South Dakota, 57701
Stacy R. Smith M.D. P.C.
Salt Lake City, Utah, 84117-5209
San Antonio Eye Center
San Antonio, Texas, 78215-1936
R and R Eye Research LLC
San Antonio, Texas, 78229
Delay Winter Eye Consultants LLC
San Antonio, Texas, 78230-5141
Samsum Clinic (DocTrials)
Santa Barbara, California, 93110
Heart of America Eye Care, P.A.
Shawnee Mission, Kansas, 662204
Northern New Jersey Eye Institute
South Orange, New Jersey, 07079-1855
DocTrials Walman Eye Center
Sun City, Arizona, 85351-3019
Office of Mark J. Weiss MD
Tulsa, Oklahoma, 74104-5300
South Shore Eye Care, LLP
Wantagh, New York, 11793
Clinical Eye Research of Boston, LLC
Winchester, Massachusetts, 01890
About this study
Official title: A Phase III, Randomized, Double-Masked, Active-Controlled, Parallel-Group, Multi-center 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 3 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. Adult subjects will receive open-label DE-117 Ophthalmic Solution for an additional 9 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 and will provide additional safety data through Month 12 for subjects receiving DE-117.
- 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 for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only
Timolol Maleate Ophthalmic Solution 0.5%Drug
Topical Timolol Maleate Ophthalmic Solution 0.5% twice daily for 3 months for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only
| 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 for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only 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 for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only 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 at Week 1
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. Analysis using Mixed-Effects Model for Repeated Measures (MMRM)
Measured: 08:00, 10:00 and 16:00 at Week 1
Intraocular Pressure at Week 6
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. Analysis using Mixed-Effects Model for Repeated Measures (MMRM)
Measured: 08:00, 10:00 and 16:00 at Week 6
Intraocular Pressure at Month 3
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. Analysis using Mixed-Effects Model for Repeated Measures (MMRM)
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)
Mean Diurnal Intraocular Pressure (IOP) at Month 3: Analysis using Mixed-Effects Model for Repeated Measures (MMRM) on observed cases.
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)
Mean Diurnal Intraocular Pressure (IOP) at Week 1: Analysis using Mixed-Effects Model for Repeated Measures (MMRM) on observed cases.
Mean Diurnal IOP at week 1 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.
- First posted2 Oct 2018
- Study start14 Sep 2018
- Primary completion6 Dec 2019
- Study completion3 Sep 2020
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
- 426 participants (actual)
Sponsor and investigators
- Lead sponsor
- Santen Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03691649
- Sponsor's protocol ID
- 011709IN
- Status last verified
- Aug 2023
- First submitted
- 28 Sep 2018
- Last updated
- 30 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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
- A Phase III, Randomized, Double-Masked, Active-Controlled, Parallel-Group, Multi-center 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 3 Study
- ClinicalTrials.gov ID
- NCT03691649
- Acronym / sponsor ID
- 011709IN
- Conditions
- Glaucoma and Ocular Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 426 participants (actual)
- Lead sponsor
- Santen Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Sep 2018 (actual)
- Primary completion
- 6 Dec 2019 (actual)
- Study completion
- 3 Sep 2020 (actual)
- First posted
- 2 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.
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. Adult subjects will receive open-label DE-117 Ophthalmic Solution for an additional 9 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 and will provide additional safety data through Month 12 for subjects receiving DE-117.
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 for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only |
| 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 for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only |
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 for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only | Drug | DE-117 Ophthalmic Solution |
| Timolol Maleate Ophthalmic Solution 0.5%Topical Timolol Maleate Ophthalmic Solution 0.5% twice daily for 3 months for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only | Drug | Timolol Maleate Ophthalmic Solution 0.5% |
Primary outcome
Intraocular Pressure at Week 1
Time frame: 08:00, 10:00 and 16:00 at Week 1
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. Analysis using Mixed-Effects Model for Repeated Measures (MMRM)
Intraocular Pressure at Week 6
Time frame: 08:00, 10:00 and 16:00 at Week 6
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. Analysis using Mixed-Effects Model for Repeated Measures (MMRM)
Intraocular Pressure at Month 3
Time frame: 08:00, 10:00 and 16:00 at Month 3
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. Analysis using Mixed-Effects Model for Repeated Measures (MMRM)
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
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.
- 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.
47 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 47 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 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 47 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?
Intraocular Pressure 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?
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.