Phase 3
Completed N=107
DE-117 Spectrum 5 Study
Primary Open-angle Glaucoma and Ocular Hypertension
Source: ClinicalTrials.gov NCT03697811 ↗
Enrolled (actual)
107
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcomePrimary: Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Month 3. — -2.96 mmHg
◆ Published Evidence
Emerging
12citations · ~4 / year
Omidenepag Isopropyl in Latanoprost Low/Nonresponders With Primary Open Angle Glaucoma or Ocular Hypertension: A Phase 3, Nonrandomized, Two-Phase, Open-Label Study.
Summary
Santen will evaluate the intraocular pressure (IOP) lowering effect and efficacy of DE-117 ophthalmic solution 0.002% in latanoprost low/non-responder subjects diagnosed with POAG or OHT
Linked Publications
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Omidenepag Isopropyl in Latanoprost Low/Nonresponders With Primary Open Angle Glaucoma or Ocular Hypertension: A Phase 3, Nonrandomized, Two-Phase, Open-Label Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Month 3. |
-2.96 | — |
| SECONDARY Percent Change From Baseline in Mean Diurnal IOP at Week 2, Week 6 and Month 3 |
-12.21; -12.40; -12.57 | — |
| SECONDARY Change From Baseline in Mean Diurnal IOP at Week 2 and Week 6 |
-2.87; -2.89 | — |
| SECONDARY Change From Baseline in IOP at Timepoints at Week 2 |
-2.52; -2.94; -3.15 | — |
| SECONDARY Change From Baseline in IOP at Timepoints at Week 6 |
-2.42; -2.86; -3.44 | — |
| SECONDARY Change From Baseline in IOP at Timepoints at Month 3 |
-2.76; -2.98; -3.08 | — |
| SECONDARY Intraocular Pressure: Percent Change From Baseline by Analysis Visit and Timepoint at Week 2 |
-10.42; -12.51; -13.47 | — |
| SECONDARY Intraocular Pressure: Percent Change From Baseline by Analysis Visit and Timepoint at Week 6 |
-10.04; -12.22; -14.80 | — |
| SECONDARY Intraocular Pressure: Percent Change From Baseline by Analysis Visit and Timepoint at Month 3 |
-11.43; -12.72; -13.13 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with Primary Open-Angle Glaucoma or Ocular Hypertension in one or both eyes.
- Provide signed written informed consent.
- Diagnosis of POAG or OHT in both eyes.
- Qualifying corrected visual acuity in each eye.
- Qualifying central corneal thickness in each eye.
- Qualifying Day 1 IOP measurement at 3 time-points in both eyes after latanoprost Run-in Period.
- Qualifying Anterior chamber angle.
- Qualifying IOP measurement at 3 time-points during latanoprost Run-in Period.
Exclusion Criteria
- Patients who cannot safely discontinue use of Ocular Hypotensive Medications during Washout.
- Patients with prior exposure to DE-117.
- History of ocular surgery specifically intended to lower IOP
- Advanced glaucoma in either eye.
- Any corneal abnormality or other condition interfering with or preventing reliable Goldmann applanation tonometry.
- Any ocular surgery or ocular laser treatment within 180 days prior to Visit 1 (Screening) and throughout the study in either eye.
- Females who are pregnant, nursing, or planning a pregnancy.
Data sourced from ClinicalTrials.gov (NCT03697811) and the linked publication. 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. Informational only — not medical advice.