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NCT03858894 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study, sponsored by Santen.
- Completed
- Registry status
- Phase 2
- Development phase
- 98
- Enrollment target
NCT03858894: Completed Phase 2 study, sponsored by Santen.
NCT03858894 is a Phase 2 study that has completed, run by Santen. The registered enrollment target is 98 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (26% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03858894, a Phase 2 study, has completed, sponsored by Santen.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 98 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg).
Interventions
- DRUG DE-117 Ophthalmic Solution QD
- DRUG DE-117 Ophthalmic Solution BID
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 98 participants |
| Start Date | 2019-01-28 |
| Est. Completion | 2019-06-20 |
| Phase | Phase 2 |
What the finished NCT03858894 record still lists
NCT03858894 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (26% lower).
The record links to 0 conditions, and to 2 interventions - of which DE-117 Ophthalmic Solution QD is the first listed.
NCT03858894 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03858894 about?
NCT03858894 is a clinical study titled "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". 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...
What is the current status of trial NCT03858894?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 98 participants. The study started on 2019-01-28. Estimated completion is 2019-06-20.
What interventions are being tested in trial NCT03858894?
The interventions under investigation include: DE-117 Ophthalmic Solution QD (DRUG), DE-117 Ophthalmic Solution BID (DRUG).
Who is sponsoring clinical trial NCT03858894?
This trial is sponsored by Santen, which has 32 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03858894's enrollment target sits among peer trials
98 743rd of 2000 higher than 1,255 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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