- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02981446
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
-
-
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Singapore, Singapore
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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
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DE-117 ophthalmic solution will be taken one drop, once daily for 3 months in both eyes.
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Active Comparator: Latanoprost ophthalmic solution 0.005%
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Latanoprost ophthalmic solution will be taken one drop, once daily for 3 months in both eyes.
Other Names:
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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.
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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
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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