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

Santen Inc.98 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Primary Open-angle Glaucoma and Ocular Hypertension

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (13)

East West Eye Institute

Los Angeles, California, United States

Danbury Eye Specialist

Danbury, Connecticut, United States

Hernando Eye Institute

Brooksville, Florida, United States

Levenson Eye Associates

Jacksonville, Florida, United States

Seidenberg Protzko Eye Associates

Havre de Grace, Maryland, United States

Tekwani Vision Center

St Louis, Missouri, United States

Eye Associates/SurgiCenter of Vineland

Vineland, New Jersey, United States

Ophthalmic Consultants of Long Island

Lynbrook, New York, United States

Apex Eye Clinical Research, LLC

Cincinnati, Ohio, United States

Abrams Eye Center

Cleveland, Ohio, United States

...and 3 more locations

Outcomes

Primary Outcomes

Intraocular Pressure (IOP) at Week 2

Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg).

Time frame: 08:00 at week 2

Intraocular Pressure (IOP) at Week 2

Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg).

Time frame: 12:00 at week 2

Intraocular Pressure (IOP) at Week 2

Intraocular pressure (IOP), the fluid pressure inside the eye, was mea...

Time frame: 16:00 at week 2

Intraocular Pressure (IOP) at Week 6

Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg).

Time frame: 08:00 at week 6

Intraocular Pressure (IOP) at Week 6

Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg).

Time frame: 12:00 at week 6

Intraocular Pressure (IOP) at Week 6

Intraocular pressure (IOP), the fluid pressure inside the eye, was mea...

Time frame: 16:00 at week 6

Secondary Outcomes

Mean Diurnal Intraocular Pressure (IOP)

Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg).

Time frame: 6 weeks