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

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Santen Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Primary Open-angle Glaucoma and Ocular Hypertension

Interventions

Type	Name	Description
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
DRUG	DE-117 Ophthalmic Solution BID	DE-117 ophthalmic solution BID twice Daily (20:00 and 8:00) add one drop in each eye

Timeline

• Start date: 2019-01-28
• Primary completion: 2019-06-20
• Completion: 2019-06-20
• First posted: 2019-03-01
• Last updated: 2020-08-04
• Results posted: 2020-08-04

Locations

13 sites across 1 country: United States

Regulatory

• FDA-regulated drug study