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NCT03691649 · 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 3 Study
A Phase 3 study, sponsored by Santen.
- Completed
- Registry status
- Phase 3
- Development phase
- 426
- Enrollment target
NCT03691649: Completed Phase 3 study, sponsored by Santen.
NCT03691649 is a Phase 3 study that has completed, run by Santen. The registered enrollment target is 426 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (45% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03691649, a Phase 3 study, has completed, sponsored by Santen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 426 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. Adult subjects will receive open-label DE-117 Ophthalmic Solution for an additional 9 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 and will provide additional safety data through Month 12 for subjects receiving DE-117.
Primary Outcome
Intraocular Pressure (IOP), the fluid pressure inside the eye was measured with calibrated Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time points throughout the day. Analysis using Mixed-Effects Model for Repeated Measures (MMRM)
Interventions
- DRUG DE-117 Ophthalmic Solution
- DRUG Timolol Maleate Ophthalmic Solution 0.5%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 426 participants |
| Start Date | 2018-09-14 |
| Est. Completion | 2020-09-03 |
| Phase | Phase 3 |
What the finished NCT03691649 record still lists
NCT03691649 is an interventional study that assigns participants to a tested intervention. The registered 426 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 (45% lower).
The record links to 0 conditions, and to 2 interventions - of which DE-117 Ophthalmic Solution is the first listed.
NCT03691649 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03691649 about?
NCT03691649 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 3 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 NCT03691649?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 426 participants. The study started on 2018-09-14. Estimated completion is 2020-09-03.
What interventions are being tested in trial NCT03691649?
The interventions under investigation include: DE-117 Ophthalmic Solution (DRUG), Timolol Maleate Ophthalmic Solution 0.5% (DRUG).
Who is sponsoring clinical trial NCT03691649?
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 NCT03691649's enrollment target sits among peer trials
426 882nd of 2000 higher than 1,118 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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