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

Status and phase: Completed; Phase 2

Conditions: Primary Open-angle Glaucoma and Ocular Hypertension

Treatments: Drug: DE-117 Ophthalmic Solution BID; Drug: DE-117 Ophthalmic Solution QD

Study type: Interventional

Funder types: Industry

Identifiers

NCT03858894

011712IN

Details and patient eligibility

About

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.

Enrollment: 98 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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98 participants in 2 patient groups

Drug Arm: DE-117 QD

Experimental group

Description:

DE-117 Ophthalmic Solution QD (20:00) and Vehicle (8:00; no active DE-117 ingredient) QD

Treatment:

Drug: DE-117 Ophthalmic Solution QD

Test Arm: DE-117 BID

Experimental group

Description:

DE-117 Ophthalmic Solution BID Twice daily (20:00 and 8:00)

Treatment:

Drug: DE-117 Ophthalmic Solution BID