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

NCT03216902 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 241

Last updated 2020-10-23

Study results available
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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

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

Sponsors & Collaborators

  • Santen Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-25
Primary Completion
2018-02-27
Completion
2018-02-27
FDA Drug
Yes

Countries

  • United States
  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03216902 on ClinicalTrials.gov