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A Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension -AYAME Study-

NCT ID: NCT02623738

Last Updated: 2017-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

253 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-06

Study Completion Date

2017-02-10

Brief Summary

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The purposes of this study are to determine the optimal concentration of DE-117 ophthalmic solution compared to the placebo ophthalmic solution and to determine if intraocular pressure reduction after 4 weeks of treatment with DE-117 ophthalmic solution is non-inferior to latanoprost ophthalmic solution 0.005%.

Detailed Description

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Conditions

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Primary Open Angle Glaucoma Ocular Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo ophthalmic solution

Eyedrop

Group Type PLACEBO_COMPARATOR

Placebo ophthalmic solution

Intervention Type DRUG

DE-117 ophthalmic solution low

Eyedrop

Group Type EXPERIMENTAL

DE-117 ophthalmic solution low

Intervention Type DRUG

DE-117 ophthalmic solution high

Eyedrop

Group Type EXPERIMENTAL

DE-117 ophthalmic solution high

Intervention Type DRUG

Latanoprost ophthalmic solution 0.005%

Eyedrop

Group Type ACTIVE_COMPARATOR

Latanoprost ophthalmic solution 0.005%

Intervention Type DRUG

Interventions

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Placebo ophthalmic solution

Intervention Type DRUG

DE-117 ophthalmic solution low

Intervention Type DRUG

DE-117 ophthalmic solution high

Intervention Type DRUG

Latanoprost ophthalmic solution 0.005%

Intervention Type DRUG

Other Intervention Names

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Latanoprost

Eligibility Criteria

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Inclusion Criteria

* Primary open angle glaucoma or ocular hypertension

Exclusion Criteria

* Patients at risk of progression of visual field loss
* Patients with severe visual field defect
* Patients with any diseases that preclude participation in this study for safety reasons
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Santen Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tokyo, Osaka, , Japan

Site Status

Countries

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Japan

References

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Aihara M, Lu F, Kawata H, Iwata A, Odani-Kawabata N, Shams NK. Omidenepag Isopropyl Versus Latanoprost in Primary Open-Angle Glaucoma and Ocular Hypertension: The Phase 3 AYAME Study. Am J Ophthalmol. 2020 Dec;220:53-63. doi: 10.1016/j.ajo.2020.06.003. Epub 2020 Jun 10.

Reference Type DERIVED
PMID: 32533949 (View on PubMed)

Other Identifiers

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01171503

Identifier Type: -

Identifier Source: org_study_id