A Phase III Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution Compared With Latanoprost Ophthalmic Solution in Subjects With OAG or OHT

March 14, 2024 updated by: Santen Pharmaceutical Co., Ltd.

A Phase III, Randomized, Observer-Masked, Active-Controlled, Parallel-Group, Multinational and Multicenter Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution 0.002% Compared With Latanoprost Ophthalmic Solution 0.005% in Subjects With Open-Angle Glaucoma or Ocular Hypertension- PEONY Study

The purpose of this study is to investigate the intraocular pressure-lowering effect and the safety of DE-117 ophthalmic solution compared with Latanoprost ophthalmic solution in subjects with open angle glaucoma or ocular hypertension.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

370

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with open angle glaucoma or ocular hypertension in both eyes

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DE-117 ophthalmic solution
Drug: DE-117
DE-117 ophthalmic solution will be taken one drop, once daily for 3 months in both eyes.
Active Comparator: Latanoprost ophthalmic solution 0.005%
Drug: Latanoprost ophthalmic solution
Latanoprost ophthalmic solution will be taken one drop, once daily for 3 months in both eyes.
Other Names:
  • Xalatan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Diurnal IOP at Month 3
Time Frame: Month 3 (average of IOP at 3 time points: 09:00, 13:00, 17:00)
The IOP (mmHg) measured in the study eye (identified at Day 1 [baseline]) was the efficacy measure for this study. The IOP was measured using a calibrated Goldmann applanation tonometer preferably by the same Investigator (operator) and the same authorized study staff (recorder) during the study for each subject.
Month 3 (average of IOP at 3 time points: 09:00, 13:00, 17:00)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IOP at 9 Timepoints (First Key Secondary Efficacy Endpoint)
Time Frame: 09:00, 13:00, and 17:00 at Week 1, Week 6, and Month 3.
The IOP (mmHg) measured in the study eye (identified at Day 1 [baseline]) was the efficacy measure for this study. The IOP was measured using a calibrated Goldmann applanation tonometer preferably by the same Investigator (operator) and the same authorized study staff (recorder) during the study for each subject.
09:00, 13:00, and 17:00 at Week 1, Week 6, and Month 3.
Mean Diurnal IOP at Week 1 (Second Key Secondary Endpoint)
Time Frame: Week 1
The IOP (mmHg) measured in the study eye (identified at Day 1 [baseline]) was the efficacy measure for this study. The IOP was measured using a calibrated Goldmann applanation tonometer preferably by the same Investigator (operator) and the same authorized study staff (recorder) during the study for each subject.
Week 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Santen Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

January 1, 2019

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

December 1, 2016

First Submitted That Met QC Criteria

December 1, 2016

First Posted (Estimated)

December 5, 2016

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 14, 2024

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01171505

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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