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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Investigator)
  • Study Primary Completion Date: January 2019

Interventions

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

Arms, Groups and Cohorts

  • Experimental: DE-117 ophthalmic solution
  • Active Comparator: Latanoprost ophthalmic solution 0.005%

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • 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.
  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Santen Pharmaceutical Co., Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor

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