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NCT04742283 · ClinicalTrials.gov registry record · Phase 2
Multicenter Study Assessing the Efficacy and Safety of DE-126 Ophthalmic Solution 0.002% Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension
A Phase 2 study, sponsored by Santen.
- Completed
- Registry status
- Phase 2
- Development phase
- 323
- Enrollment target
NCT04742283 is a Phase 2 study that has completed, run by Santen. The registered enrollment target is 323 participants.
The verdict
NCT04742283, a Phase 2 study, has completed, sponsored by Santen.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 323 participants
- Enrollment target
Study Summary
Reduction of elevated pressure in the eye (Intraocular pressure, or 'IOP') with eye drop medications has been shown to be effective in delaying or preventing the progression of glaucoma, and it is the only proven method for reducing the risk of glaucomatous visual field loss. This study is being conducted to determine how well DE-126 ophthalmic solution works (efficacy) in safely lowering IOP when dosed as topical eyedrops. This study will evaluate the safety and efficacy of DE-126, ophthalmic solution in subjects with Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT). The IOP will be measured at 3 different times throughout the day, over 4 total visits during a 3-month treatment period (with up to 4 extra weeks observation if the patient must stop taking current eye drops to lower IOP). Safety assessments will be done throughout the study, including ocular signs and symptoms, and vital signs. While the most important time-point to measure IOP in this study and evaluate efficacy will be at the final study visit (month 3), IOP values will also be evaluated at other visits throughout the 3-month treatment period.
Interventions
- DRUG Timolol Maleate Ophthalmic Solution 0.5% BID
- DRUG DE-126 Ophthalmic Solution 0.002% QD
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 323 participants |
| Start Date | 2020-12-17 |
| Est. Completion | 2021-12-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04742283
The ClinicalTrials.gov registry entry for NCT04742283 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 323 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 Timolol Maleate Ophthalmic Solution 0.5% BID is the first listed.
NCT04742283 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04742283 about?
NCT04742283 is a clinical study titled "Multicenter Study Assessing the Efficacy and Safety of DE-126 Ophthalmic Solution 0.002% Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension". Reduction of elevated pressure in the eye (Intraocular pressure, or 'IOP') with eye drop medications has been shown to be effective in delaying or preventing the progression of glaucoma, and it is the only proven method for reducing the risk of glaucomatous visual field loss. This study is being co...
What is the current status of trial NCT04742283?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 323 participants. The study started on 2020-12-17. Estimated completion is 2021-12-07.
What interventions are being tested in trial NCT04742283?
The interventions under investigation include: Timolol Maleate Ophthalmic Solution 0.5% BID (DRUG), DE-126 Ophthalmic Solution 0.002% QD (DRUG).
Who is sponsoring clinical trial NCT04742283?
This trial is sponsored by Santen, which has 32 total clinical trials registered on ClinicalTrials.gov.
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