Phase 2
Completed N=98
Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution Once Daily and Twice Daily in Subjects With Primary Open-Angle Glaucoma SPECTRUM 6
Primary Open-angle Glaucoma and Ocular Hypertension
Source: ClinicalTrials.gov NCT03858894 ↗
Enrolled (actual)
98
Serious AEs
1.0%
Results posted
Aug 2020
Primary outcomePrimary: Intraocular Pressure (IOP) at Week 2 — 18.19; 19.15 mmHg
Summary
This is a randomized, double-masked, parallel-group, multi-center study. Subjects diagnosed with POAG or OHT who meet eligibility criteria at Visit 1 (Screening) will wash out 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 Visit 2 (Baseline, Day 1) will be randomized to receive study medication for up to 6 weeks.
Approximately 100 subjects with POAG or OHT will be randomized in a 1:1 ratio to either:
* DE-117 ophthalmic solution 0.002% QD (Once Daily)
* DE-117 ophthalmic solution 0.002% BID (Twice Daily)
This study will consist of a screening period of up to 35 days including a washout period of up to 28 days (+ 7 days window), and a 6-week double-masked treatment period.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intraocular Pressure (IOP) at Week 2 |
16.73; 17.81 | — |
| PRIMARY Intraocular Pressure (IOP) at Week 6 |
17.30; 17.66 | — |
| SECONDARY Mean Diurnal Intraocular Pressure (IOP) |
17.77; 18.37 | — |
Eligibility Criteria
Inclusion Criteria
Provide signed written informed consent
- Have a diagnosis of POAG or OHT in both eyes, or one eye with POAG and the other with OHT.
- 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
- Qualifying Anterior chamber angle
Exclusion Criteria
- History of ocular surgery specifically intended to lower IOP
- Subjects who cannot safely discontinue use of ocular hypotensive medications during the wait/washout period
- 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 Screening and throughout the study in either eye
- Females who are pregnant, nursing, or planning a pregnancy
Data sourced from ClinicalTrials.gov (NCT03858894). 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.