Phase 3
N=426
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
Glaucoma and Ocular Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT03691649 ↗Enrolled (actual)
426
Serious AEs
2.6%
Results posted
Aug 2023
Primary outcome: Primary: Intraocular Pressure at Week 1 — 19.0; 19.1; 18.0; 18.2 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- DE-117 Ophthalmic Solution (Drug); Timolol Maleate Ophthalmic Solution 0.5% (Drug)
- Age
- Pediatric, Adult, Older Adult · 0+ yrs
- Sex
- All
- Sponsor
- Santen Inc.
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intraocular Pressure at Week 1 |
19.0; 19.1; 18.0; 18.2; 17.5; 17.9 | — |
| PRIMARY Intraocular Pressure at Week 6 |
19.8; 18.4; 18.9; 18.0; 18.5; 17.7 | — |
| PRIMARY Intraocular Pressure at Month 3 |
19.7; 18.5; 18.8; 17.7; 18.6; 17.8 | — |
| SECONDARY Mean Diurnal Intraocular Pressure (IOP) at Month 3 (First Key Secondary Endpoint) |
19.0; 18.0 | — |
| SECONDARY Intraocular Pressure (IOP) at Week 1 With Baseline Mean Diurnal IOP Less Than 25 mmHg (Second Key Secondary Endpoint) |
17.9; 18.2; 17.2; 17.3; 16.8; 17.2 | — |
| SECONDARY Intraocular Pressure (IOP) at Week 6 With Baseline Mean Diurnal IOP Less Than 25 mmHg (Second Key Secondary Endpoint) |
18.7; 17.8; 18.0; 17.4; 17.6; 17.1 | — |
| SECONDARY Intraocular Pressure (IOP) at Month 3 With Baseline Mean Diurnal IOP Less Than 25 mmHg (Second Key Secondary Endpoint) |
18.6; 17.7; 17.8; 16.9; 17.7; 17.2 | — |
| SECONDARY Mean Diurnal Intraocular Pressure (IOP) at Week 1 (Third Key Secondary Endpoint) |
18.1; 18.4 | — |
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.
Eligibility Criteria
Inclusion Criteria
- glaucoma or ocular hypertension
Exclusion Criteria
- Females who are pregnant, nursing, or planning a pregnancy
- Any corneal abnormality or other condition interfering with or preventing reliable tonometric measurements
Data sourced from ClinicalTrials.gov (NCT03691649). 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.