Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03691662 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study, sponsored by Santen.
- Completed
- Registry status
- Phase 3
- Development phase
- 417
- Enrollment target
NCT03691662 is a Phase 3 study that has completed, run by Santen. The registered enrollment target is 417 participants.
The verdict
NCT03691662, a Phase 3 study, has completed, sponsored by Santen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 417 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG DE-117 Ophthalmic Solution
- DRUG Timolol Maleate Ophthalmic Solution 0.5%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 417 participants |
| Start Date | 2018-09-27 |
| Est. Completion | 2019-10-23 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03691662
The ClinicalTrials.gov registry entry for NCT03691662 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 417 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 is the first listed.
NCT03691662 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03691662 about?
NCT03691662 is a clinical study titled "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". 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 ...
What is the current status of trial NCT03691662?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 417 participants. The study started on 2018-09-27. Estimated completion is 2019-10-23.
What interventions are being tested in trial NCT03691662?
The interventions under investigation include: DE-117 Ophthalmic Solution (DRUG), Timolol Maleate Ophthalmic Solution 0.5% (DRUG).
Who is sponsoring clinical trial NCT03691662?
This trial is sponsored by Santen, which has 32 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.