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

Open Angle Glaucoma or Ocular Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02981446
• Other study ID #: 01171505
• Status: Completed
• Phase: Phase 3
• Start date: January 2017
• Est. completion date: January 2019

Study information

• Verified date: June 2019
• Source: Santen Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 370
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Open Angle Glaucoma or Ocular Hypertension

Intervention

Drug:
• DE-117
DE-117 ophthalmic solution will be taken one drop, once daily for 3 months in both eyes.
• Latanoprost ophthalmic solution
Latanoprost ophthalmic solution will be taken one drop, once daily for 3 months in both eyes.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Santen Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Diurnal IOP at 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.	Month 3 (average of IOP at 3 time points: 09:00, 13:00, 17:00)
Secondary	IOP at 9 Timepoints (First Key Secondary Efficacy Endpoint)	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.
Secondary	Mean Diurnal IOP at Week 1 (Second Key Secondary Endpoint)	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