NCT03691662

A Phase III Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Glaucoma or Ocular Hypertension - Spectrum 4 Study

A Phase III, Randomized, Double-Masked, Active-Controlled, Parallel-Group, Multicenter Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Glaucoma or Ocular Hypertension - Spectrum 4 Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 417 (actual)
• Sponsor: Santen Inc. · Industry
• Sex: All
• Age: 12 Months
• Healthy volunteers: Not accepted

Summary

This is a Phase III, randomized, double-masked, active-controlled, parallel-group, multi-center study. Subjects diagnosed with glaucoma or OHT who meet eligibility criteria at Visit 1 (Screening) will washout of 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 baseline will be randomized to receive double-masked treatment for 3 months. Approximately 400 adult subjects and up to 30 pediatric subjects with glaucoma or OHT who meet all eligibility criteria will be randomized in a 1:1 ratio to receive either: * DE-117 Ophthalmic Solution once daily and Vehicle once daily, or * Timolol Maleate Ophthalmic Solution 0.5% twice daily. The study will evaluate the efficacy and safety of DE-117 Ophthalmic Solution compared with Timolol Maleate Ophthalmic Solution 0.5% in subjects with glaucoma or OHT through Month 3.

Conditions

• Glaucoma and Ocular Hypertension

Interventions

Type	Name	Description
DRUG	DE-117 Ophthalmic Solution	Topical DE-117 Ophthalmic Solution once daily and Vehicle once daily for 3 months
DRUG	Timolol Maleate Ophthalmic Solution 0.5%	Topical Timolol Maleate Ophthalmic Solution 0.5% twice daily for 3 months

Timeline

• Start date: 2018-09-27
• Primary completion: 2019-10-23
• Completion: 2019-10-23
• First posted: 2018-10-02
• Last updated: 2023-08-09
• Results posted: 2023-08-09

Locations

34 sites across 1 country: United States

Regulatory

• FDA-regulated drug study