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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 is a Phase 2 study that has completed, run by Santen. The registered enrollment target is 98 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03858894
The ClinicalTrials.gov registry entry for NCT03858894 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 98 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Santen, which has 32 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which DE-117 Ophthalmic Solution QD is the first listed.
NCT03858894 reports 0 study locations.
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.
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