NCT03216902

A Phase IIb Safety and Efficacy Study of DE-126 Ophthalmic Solution in Primary Open-Angle Glaucoma or Ocular Hypertension- Angel Study

A Phase IIb, Randomized, Observer-Masked, Placebo- and Active-Controlled, Parallel-Group, Multinational and Multicenter Study Assessing the Safety and Efficacy of DE-126 Ophthalmic Solution in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension- Angel Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 241 (actual)
• Sponsor: Santen Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Treatment of elevated pressure in the eye (Intraocular pressure, or 'IOP') with eye drop medications has been shown to be effective in delaying or preventing the progression of glaucoma, and it is the only proven method for reducing the risk of glaucomatous visual field loss. This study is being conducted to determine how well DE-126 ophthalmic solution works (efficacy) in safely lowering IOP when dosed as topical eyedrops. This study will evaluate the safety and efficacy of four (4) concentrations of DE-126, when compared with latanoprost (0.005%) eye drops in patients with primary open-angle glaucoma or ocular hypertension. The IOP will be measured at 3 different times throughout the day, over 6 total visits during a 3-month treatment period (with up to 4 extra weeks observation if the patient must stop taking current eye drops to lower IOP). Safety assessments will be done throughout the study, including ocular signs and symptoms, vital signs, and clinical laboratory tests. While the most important time-point to measure IOP in this study and evaluate efficacy will be at the final study visit (month 3), IOP values will also be evaluated at other visits throughout the 3-month treatment period.

Conditions

• Open-angle Glaucoma, Ocular Hypertension

Interventions

Type	Name	Description
DRUG	Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution	Vehicle of DE-126 Ophthalmic Solution dosed once daily for 6weeks, followed by high dose of DE-126 dosed once daily for 6 additional weeks
DRUG	Topical ultra-low dose of DE-126 Ophthalmic Solution	Topical ultra-low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
DRUG	Topical low dose of DE-126 Ophthalmic Solution	Topical low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
DRUG	Topical medium dose of DE-126 Ophthalmic Solution	Topical medium dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
DRUG	Topical high dose of DE-126 Ophthalmic Solution	Topical high dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
DRUG	0.005% Latanoprost Ophthalmic Solution	0.005% Latanoprost Ophthalmic Solution dosed once daily for 12 weeks

Timeline

• Start date: 2017-07-25
• Primary completion: 2018-02-27
• Completion: 2018-02-27
• First posted: 2017-07-13
• Last updated: 2020-10-23
• Results posted: 2020-10-23

Locations

17 sites across 2 countries: United States, Japan

Regulatory

• FDA-regulated drug study