Phase 3
N=370
A Phase III Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution Compared With Latanoprost Ophthalmic Solution in Subjects With OAG or OHT
Open Angle Glaucoma or Ocular Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT02981446 ↗Enrolled (actual)
370
Serious AEs
1.1%
Results posted
Mar 2024
Primary outcome: Primary: Mean Diurnal IOP at Month 3 — 17.5; 16.8 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- DE-117 (Drug); Latanoprost ophthalmic solution (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Santen Pharmaceutical Co., Ltd.
- Primary completion
- Jan 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Diurnal IOP at Month 3 |
17.5; 16.8 | — |
| SECONDARY IOP at 9 Timepoints (First Key Secondary Efficacy Endpoint) |
19.0; 18.8; 18.4; 18.4; 18.0; 18.3 | — |
| SECONDARY Mean Diurnal IOP at Week 1 (Second Key Secondary Endpoint) |
18.5; 18.5 | — |
Summary
The purpose of this study is to investigate the intraocular pressure-lowering effect and the safety of DE-117 ophthalmic solution compared with Latanoprost ophthalmic solution in subjects with open angle glaucoma or ocular hypertension.
Eligibility Criteria
Inclusion Criteria
- Patients with open angle glaucoma or ocular hypertension in both eyes
Exclusion Criteria
- Patients at risk of progression of visual field loss
- Patients with severe visual field defect
- Patients with any diseases that preclude participation in this study for safety reasons
Data sourced from ClinicalTrials.gov (NCT02981446). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.