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 Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03858894
• Other study ID #: 011712IN
• Status: Completed
• Phase: Phase 2
• Start date: January 28, 2019
• Est. completion date: June 20, 2019

Study information

• Verified date: July 2020
• Source: Santen Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: June 20, 2019
• Est. primary completion date: June 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Primary Open-angle Glaucoma and Ocular Hypertension

Intervention

Drug:
• DE-117 Ophthalmic Solution QD
DE-117 ophthalmic solution QD and Vehicle (no active DE-117 ingredient) QD add one drop in each eye
• DE-117 Ophthalmic Solution BID
DE-117 ophthalmic solution BID twice Daily (20:00 and 8:00) add one drop in each eye

Locations

Country	Name	City	State
United States	Hernando Eye Institute	Brooksville	Florida
United States	Apex Eye Clinical Research, LLC	Cincinnati	Ohio
United States	Abrams Eye Center	Cleveland	Ohio
United States	Scott & Christie and Associates PC	Cranberry Township	Pennsylvania
United States	Danbury Eye Specialist	Danbury	Connecticut
United States	Seidenberg Protzko Eye Associates	Havre De Grace	Maryland
United States	Levenson Eye Associates	Jacksonville	Florida
United States	East West Eye Institute	Los Angeles	California
United States	Ophthalmic Consultants of Long Island	Lynbrook	New York
United States	University Eye Specialist	Maryville	Tennessee
United States	Advanced Vision Research	Nashville	Tennessee
United States	Tekwani Vision Center	Saint Louis	Missouri
United States	Eye Associates/SurgiCenter of Vineland	Vineland	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Santen Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular Pressure (IOP) at Week 2	Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg).	08:00 at week 2
Primary	Intraocular Pressure (IOP) at Week 2	Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg).	12:00 at week 2
Primary	Intraocular Pressure (IOP) at Week 2	Intraocular pressure (IOP), the fluid pressure inside the eye, was mea...	16:00 at week 2
Primary	Intraocular Pressure (IOP) at Week 6	Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg).	08:00 at week 6
Primary	Intraocular Pressure (IOP) at Week 6	Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg).	12:00 at week 6
Primary	Intraocular Pressure (IOP) at Week 6	Intraocular pressure (IOP), the fluid pressure inside the eye, was mea...	16:00 at week 6
Secondary	Mean Diurnal Intraocular Pressure (IOP)	Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg).	6 weeks