Clinical trial NCT03858894: 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
Official title: A Randomized, Double-Masked, Parallel-Group, Multicenter Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution 0.002% Once Daily and Twice Daily in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension SPECTRUM 6 Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Primary Open-angle Glaucoma and Ocular Hypertension
Lead sponsor: Santen Inc.
Sponsor class: INDUSTRY
First posted: 2019-03-01
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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

Primary outcomes:
measure: Intraocular Pressure (IOP) at Week 2
timeFrame: 08:00 at week 2
measure: Intraocular Pressure (IOP) at Week 2
timeFrame: 12:00 at week 2
measure: Intraocular Pressure (IOP) at Week 2
timeFrame: 16:00 at week 2
measure: Intraocular Pressure (IOP) at Week 6
timeFrame: 08:00 at week 6
measure: Intraocular Pressure (IOP) at Week 6
timeFrame: 12:00 at week 6
measure: Intraocular Pressure (IOP) at Week 6
timeFrame: 16:00 at week 6
Secondary outcomes:
measure: Mean Diurnal Intraocular Pressure (IOP)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: East West Eye Institute
state: California
city: Danbury
country: United States
facility: Danbury Eye Specialist
state: Connecticut
city: Brooksville
country: United States
facility: Hernando Eye Institute
state: Florida
city: Jacksonville
country: United States
facility: Levenson Eye Associates
state: Florida
city: Havre De Grace
country: United States
facility: Seidenberg Protzko Eye Associates
state: Maryland
city: Saint Louis
country: United States
facility: Tekwani Vision Center
state: Missouri
city: Vineland
country: United States
facility: Eye Associates/SurgiCenter of Vineland
state: New Jersey
city: Lynbrook
country: United States
facility: Ophthalmic Consultants of Long Island
state: New York
city: Cincinnati
country: United States
facility: Apex Eye Clinical Research, LLC
state: Ohio
city: Cleveland
country: United States
facility: Abrams Eye Center
state: Ohio
city: Cranberry Township
country: United States
facility: Scott & Christie and Associates PC
state: Pennsylvania
city: Maryville
country: United States
facility: University Eye Specialist
state: Tennessee
city: Nashville
country: United States
facility: Advanced Vision Research
state: Tennessee
Study officials:
References: