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

Santen

Status and phase: Completed; Phase 2

Conditions: Open-angle Glaucoma, Ocular Hypertension

Treatments: Drug: Topical high dose of DE-126 Ophthalmic Solution; Drug: Topical medium dose of DE-126 Ophthalmic Solution; Drug: 0.005% Latanoprost Ophthalmic Solution; Drug: Topical ultra-low dose of DE-126 Ophthalmic Solution; Drug: Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution; Drug: Topical low dose of DE-126 Ophthalmic Solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT03216902

012601IN

Details and patient eligibility

About

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.

Enrollment: 241 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Provide signed written informed consent
• Diagnosis of POAG or OHT in both eyes
• 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 90 days prior to Visit 1 (Screening) and throughout the study in either eye
• Females who are pregnant, nursing, or planning a pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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241 participants in 6 patient groups, including a placebo group

Placebo (Vehicle of DE-126) followed by high dose of DE-126

Placebo Comparator group

Treatment:

Drug: Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution

Ultra-low dose 0.0005% DE-126

Experimental group

Treatment:

Drug: Topical ultra-low dose of DE-126 Ophthalmic Solution

Low dose 0.001% DE-126

Experimental group

Treatment:

Drug: Topical low dose of DE-126 Ophthalmic Solution

Medium dose 0.002% DE-126

Experimental group

Treatment:

Drug: Topical medium dose of DE-126 Ophthalmic Solution

High dose 0.003% DE-126

Experimental group

Treatment:

Drug: Topical high dose of DE-126 Ophthalmic Solution

0.005% Latanoprost

Active Comparator group

Treatment:

Drug: 0.005% Latanoprost Ophthalmic Solution