NCT03697811

DE-117 Spectrum 5 Study

An Open-Label, Multicenter Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution 0.002% in Latanoprost Low/Non-Responder Subjects Diagnosed With Primary Open-Angle Glaucoma or Ocular Hypertension - Spectrum 5 Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 107 (actual)
• Sponsor: Santen Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Santen will evaluate the intraocular pressure (IOP) lowering effect and efficacy of DE-117 ophthalmic solution 0.002% in latanoprost low/non-responder subjects diagnosed with POAG or OHT

Conditions

• Primary Open-angle Glaucoma and Ocular Hypertension

Interventions

Type	Name	Description
DRUG	DE-117 Ophthalmic Solution	Interventional treatment will be made with DE-117 Ophthalmic Solution 0.002% once daily in the evening for the duration of the 3 month treatment period.

Timeline

• Start date: 2018-09-27
• Primary completion: 2022-01-13
• Completion: 2022-01-13
• First posted: 2018-10-05
• Last updated: 2023-08-30
• Results posted: 2023-08-30

Locations

32 sites across 1 country: United States

Regulatory

• FDA-regulated drug study