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
Public ClinicalTrials.gov record NCT03858894. 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 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.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03858894
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 98 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years 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
- Jan 27, 2019
- Primary completion
- Jun 19, 2019
- Completion
- Jun 19, 2019
- Last update posted
- Aug 3, 2020
2019
United States locations
- U.S. sites
- 13
- U.S. states
- 10
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| East West Eye Institute | Los Angeles | California | 90013 | — |
| Danbury Eye Specialist | Danbury | Connecticut | 06810 | — |
| Hernando Eye Institute | Brooksville | Florida | 34613 | — |
| Levenson Eye Associates | Jacksonville | Florida | 32204 | — |
| Seidenberg Protzko Eye Associates | Havre de Grace | Maryland | 21078 | — |
| Tekwani Vision Center | St Louis | Missouri | 63128 | — |
| Eye Associates/SurgiCenter of Vineland | Vineland | New Jersey | 08361 | — |
| Ophthalmic Consultants of Long Island | Lynbrook | New York | 11563 | — |
| Apex Eye Clinical Research, LLC | Cincinnati | Ohio | 45242 | — |
| Abrams Eye Center | Cleveland | Ohio | 44115 | — |
| Scott & Christie and Associates PC | Cranberry Township | Pennsylvania | 16066 | — |
| University Eye Specialist | Maryville | Tennessee | 37803 | — |
| Advanced Vision Research | Nashville | Tennessee | 37205 | — |
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 NCT03858894, 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 3, 2020 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03858894 live on ClinicalTrials.gov.