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NCT03697811 · ClinicalTrials.gov registry record · Phase 3
DE-117 Spectrum 5 Study
A Phase 3 study of Primary Open-angle Glaucoma and Ocular Hypertension, sponsored by Santen.
- Completed
- Registry status
- Phase 3
- Development phase
- 107
- Enrollment target
- 20
- Study locations
NCT03697811: Completed Phase 3 study of Primary Open-angle Glaucoma and Ocular Hypertension, sponsored by Santen.
NCT03697811 is a Phase 3 study of Primary Open-angle Glaucoma and Ocular Hypertension that has completed, run by Santen. The registered enrollment target is 107 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03697811, a Phase 3 study of Primary Open-angle Glaucoma and Ocular Hypertension, has completed, sponsored by Santen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 107 participants
- Enrollment target
- 20
- Study locations
Study Summary
Santen will evaluate the intraocular pressure (IOP) lowering effect and efficacy of DE-117 ophthalmic solution 0.002% in latanoprost low/non-responder subjects diagnosed with POAG or OHT
Primary Outcome
IOP lowering effect of DE-117 ophthalmic solution 0.002% in Latanoprost low/non-responder subjects. Mean Diurnal Intraocular Pressure: Analysis of Change from Baseline in IOP score at Month 3 using Paired T-test on Observed Case. Mean Diurnal IOP is defined as the average IOP of all three timepoints (8:00,12:00, 16:00) at Month 3.
Conditions Studied
Interventions
- DRUG DE-117 Ophthalmic Solution
Study Locations (20)
California
- Global Research Management - Glendale
- North Valley Eye Medical Group - Mission Hills
- Eye Research Foundation - Newport Beach
- North Bay Eye Associates - Petaluma
- Martel Eye Medical Group - Rancho Cordova
Georgia
- Dixon Eye Care - Albany
- Clayton Eye Clinical Research, LLC - Morrow
- Coastal Research Associates, LEC - Roswell
New York
- NYU Langone Health Department of Ophthalmology - New York
- Rochester Ophthalmological Group, PC - Rochester
- South Shore Eye Center - Wantagh
Florida
- Shettle Eye Research, Inc. - Largo
- International Eye Associates, PA - Ormond Beach
Missouri
- Tekwani Vision Center - St Louis
- Comprehensive Eye Care Ltd - Washington
North Carolina
- Asheville Eye Associates, PLLC - Asheville
- Mundorf Eye Center - Charlotte
Arizona
- Arizona Eye Center - Chandler
Connecticut
- Danbury Eye Physicians & Surgeons - Danbury
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 107 participants |
| Start Date | 2018-09-27 |
| Est. Completion | 2022-01-13 |
| Phase | Phase 3 |
What the finished NCT03697811 record still lists
NCT03697811 is an interventional study that assigns participants to a tested intervention. The registered 107 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower).
The record links to 1 condition, with Primary Open-angle Glaucoma and Ocular Hypertension appearing as the primary indexed condition, and to 1 intervention - of which DE-117 Ophthalmic Solution is the first listed.
NCT03697811 names 20 study sites across 9 states, led by California, Georgia, New York.
Frequently Asked Questions
What is clinical trial NCT03697811 about?
NCT03697811 is a clinical study titled "DE-117 Spectrum 5 Study". Santen will evaluate the intraocular pressure (IOP) lowering effect and efficacy of DE-117 ophthalmic solution 0.002% in latanoprost low/non-responder subjects diagnosed with POAG or OHT
What is the current status of trial NCT03697811?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 107 participants. The study started on 2018-09-27. Estimated completion is 2022-01-13.
What conditions does trial NCT03697811 study?
This clinical trial studies the following conditions: Primary Open-angle Glaucoma and Ocular Hypertension.
What interventions are being tested in trial NCT03697811?
The interventions under investigation include: DE-117 Ophthalmic Solution (DRUG).
Who is sponsoring clinical trial NCT03697811?
This trial is sponsored by Santen, which has 32 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03697811 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03697811's enrollment target sits among peer trials
107 1666th of 2000 higher than 335 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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