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

Phase 3

Completed

• Conditions: Open Angle Glaucoma or Ocular Hypertension
• Interventions: Drug: DE-117; Drug: Latanoprost ophthalmic solution

• Registration Number: NCT02981446
• Lead Sponsor: Santen Pharmaceutical Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-12-01
• Study First Submitted QC: 2016-12-01
• Study First Posted: 2016-12-05
• Study Start: 2017-01
• Primary Completion: 2019-01
• Study Completion: 2019-01
• Status Verified: 2019-06
• Results First Submitted: 2023-08-02
• Results First Submitted QC: 2024-03-14
• Last Update Submitted: 2024-03-14
• Results First Posted: 2024-03-15
• Last Update Posted: 2024-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 370

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DE-117 ophthalmic solution	DE-117	-
Latanoprost ophthalmic solution 0.005%	Latanoprost ophthalmic solution	-

Primary Outcome Measures

Name	Time	Method
Mean Diurnal IOP at Month 3	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.

Secondary Outcome Measures

Name	Time	Method
IOP at 9 Timepoints (First Key Secondary Efficacy Endpoint)	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.
Mean Diurnal IOP at Week 1 (Second Key Secondary Endpoint)	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.