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
Public ClinicalTrials.gov record NCT03691662. 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, 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
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. 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 identification
- NCT ID
- NCT03691662
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 417 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 27, 2018 (Actual)
- Primary completion
- Oct 23, 2019 (Actual)
- Completion
- Oct 23, 2019 (Actual)
- Last update posted
- Aug 9, 2023
2018 – 2019
United States locations
- U.S. sites
- 34
- U.S. states
- 16
- U.S. cities
- 32
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Eye Center | Chandler | Arizona | 85224 | — |
| M & M Eye Institute | Prescott | Arizona | 86301-6610 | — |
| Global Research Management | Glendale | California | 91204 | — |
| United Medical Research Inst | Inglewood | California | 90301 | — |
| Eye Research Foundation | Newport Beach | California | 92663-3642 | — |
| North Bay Eye Associates Inc. | Petaluma | California | 94954-2387 | — |
| Sacramento Eye Consultants | Sacramento | California | 95815-4605 | — |
| AdvanceMed Clinical Research | San Diego | California | 92122 | — |
| Michael K. Tran, MD, Inc. | Westminster | California | 92683-7071 | — |
| Haas Vision Center | Colorado Springs | Colorado | 80919-5913 | — |
| Florida Ophthalmic Institute | Gainesville | Florida | 32605-3192 | — |
| St. Michaels Eye Laser Institute | Largo | Florida | 33770-3225 | — |
| International Eye Associates PA | Ormond Beach | Florida | 32174 | — |
| East Florida Eye Institute | Stuart | Florida | 34994 | — |
| Clayton Eye Clinical Research, LLC | Morrow | Georgia | 30260 | — |
| Seidenberg Protzko Eye Associates | Havre de Grace | Maryland | 21078 | — |
| Great Lakes Eye Care P.C | Saint Joseph | Michigan | 49085 | — |
| Discover Vision Centers | Independence | Missouri | 64055-6974 | — |
| Silverstein Eye Centers | Kansas City | Missouri | 64133 | — |
| Comprehensive Eye Care Ltd. | Washington | Missouri | 63090-3010 | — |
| AdvanceMed Clinical Research | Las Vegas | Nevada | 89123 | — |
| Rochester Ophthalmological Group, PC | Rochester | New York | 14618 | — |
| Asheville Eye Associates | Asheville | North Carolina | 28803-2493 | — |
| Abrams Eye Center | Cleveland | Ohio | 44115 | — |
| Total Eye Care PA | Memphis | Tennessee | 38119-5770 | — |
| VRF Eye Specialty Group | Memphis | Tennessee | 38120 | — |
| Glaucoma Associates of Texas | Dallas | Texas | 75231-2168 | — |
| Houston Eye Associates HEA - Gramercy Location | Houston | Texas | 77025-1756 | — |
| Baylor College of Medicine Alkek Eye Center | Houston | Texas | 77030 | — |
| The Eye Clinic of Texas | League City | Texas | 77573-5148 | — |
| Medical Center Ophthalmology Associates | San Antonio | Texas | 78240-1502 | — |
| Stacy R. Smith M.D. P.C. | Salt Lake City | Utah | 84117 | — |
| Vistar Eye Center | Roanoke | Virginia | 24016-5100 | — |
| Tidewater Clinical Research | Virginia Beach | Virginia | 23456 | — |
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 NCT03691662, 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 9, 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 NCT03691662 live on ClinicalTrials.gov.