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
Public ClinicalTrials.gov record NCT03691649. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT03691649
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 426 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 12 Months and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 14, 2018 (Actual)
- Primary completion
- Dec 6, 2019 (Actual)
- Completion
- Sep 3, 2020 (Actual)
- Last update posted
- Aug 30, 2023
2018 – 2020
United States locations
- U.S. sites
- 47
- U.S. states
- 23
- U.S. cities
- 43
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Glaucoma Specialists | Phoenix | Arizona | 85050 | — |
| DocTrials Walman Eye Center | Sun City | Arizona | 85351-3019 | — |
| Havana Research Institute | Burbank | California | 91506 | — |
| Macy Eye Center | Los Angeles | California | 90048-6149 | — |
| North Valley Eye Medical Group | Mission Hills | California | 91345 | — |
| North Bay Eye Associates, Inc | Petaluma | California | 94954 | — |
| Martel Eye Medical Group | Rancho Cordova | California | 95670 | — |
| Samsum Clinic (DocTrials) | Santa Barbara | California | 93110 | — |
| MCB Clinical Research Centers LLC | Colorado Springs | Colorado | 80909 | — |
| Hernando Eye Institute | Brooksville | Florida | 34613-6065 | — |
| Eye Associates of Fort Myers | Fort Myers | Florida | 33901-9311 | — |
| Bowden Eye & Associates | Jacksonville | Florida | 32256 | — |
| Shettle Eye Research | Largo | Florida | 33773 | — |
| Dixophthal PC Dba. Dixon Eye Care | Albany | Georgia | 31701-2363 | — |
| Coastal Research Associates | Alpharetta | Georgia | 30076 | — |
| Clayton Eye Clinical Research, LLC | Morrow | Georgia | 30260 | — |
| Indiana University | Bloomington | Indiana | 47405 | — |
| Heart of America Eye Care, P.A. | Shawnee Mission | Kansas | 662204 | — |
| Clinical Eye Research of Boston, LLC | Winchester | Massachusetts | 01890 | — |
| Tauber Eye Center | Kansas City | Missouri | 64111 | — |
| 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 | — |
| Northern New Jersey Eye Institute | South Orange | New Jersey | 07079-1855 | — |
| NY Eye & ear Infirmary of Mt Sinai (NYEE) | New York | New York | 10003 | — |
| South Shore Eye Care, LLP | Wantagh | New York | 11793 | — |
| Asheville Eye Associates | Asheville | North Carolina | 28803-2493 | — |
| Charlotte Eye Ear Nose & Throat Associates, PA | Charlotte | North Carolina | 28210 | — |
| Cornerstone Eye Care | High Point | North Carolina | 27262 | — |
| Apex Eye Clinical Research, LLC | Cincinnati | Ohio | 45242 | — |
| Ophthalmic Surgeons & Consultants of Ohio, Inc. | Columbus | Ohio | 43215 | — |
| Office of Mark J. Weiss MD | Tulsa | Oklahoma | 74104-5300 | — |
| Scott & Christie and Associates PC | Cranberry Township | Pennsylvania | 16066 | — |
| Glaucoma Consultants and Center for Eye Research PA | Mt. Pleasant | South Carolina | 29464-8298 | — |
| Black Hills Regional Eye Institute, LLP | Rapid City | South Dakota | 57701 | — |
| University Eye Specialists | Maryville | Tennessee | 37803 | — |
| Total Eye Care PA | Memphis | Tennessee | 38119-5770 | — |
| Keystone Research Ltd. Texan Eye PA | Austin | Texas | 78731-4203 | — |
| The Cataract and Glaucoma Center | El Paso | Texas | 79902 | — |
| Ophthalmology Associates | Fort Worth | Texas | 76102 | — |
| Shah Research LLC dba Discovery Clinical Trials | Mission | Texas | 78572-2425 | — |
| 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 | — |
| Stacy R. Smith M.D. P.C. | Salt Lake City | Utah | 84117-5209 | — |
| Emerson Clinical Research Institute | Falls Church | Virginia | 22046 | — |
| Specialty Eye Care Centre | Bellevue | Washington | 98004 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03691649, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 30, 2023 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03691649 live on ClinicalTrials.gov.