Phase 3 N=107 Treatment

DE-117 Spectrum 5 Study

Primary Open-angle Glaucoma and Ocular Hypertension

Bottom Line

View on ClinicalTrials.gov: NCT03697811 ↗

Enrolled (actual)

107

Serious AEs

0.0%

Results posted

Aug 2023

Primary outcome: Primary: Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Month 3. — -2.96 mmHg

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: DE-117 Ophthalmic Solution (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Santen Inc.
Primary completion: Jan 2022

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	—

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

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03697811). 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.