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

• Status: Completed
• Trial end date: 2019-06-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Santen Inc.
• Treatments: Ophthalmic Solutions; Pharmaceutical Solutions

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