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A Phase III Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution Compared With Latanoprost Ophthalmic Solution in Subjects With Open-Angle Glaucoma or Ocular Hypertension

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 - PEONY

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/05/008638
Enrollment
360
Registered
2017-05-24
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H401- Open-angle glaucoma Health Condition 2: null- Open-Angle Glaucoma or Ocular Hypertension- PEONY Study

Interventions

Intervention1: DE-117: 0.002% DE-117 Ophthalmic Solution - one drop once daily in both eyes for 3 months Control Intervention1: Latanoprost: 0.005% Latanoprost Ophthalmic Solution - one drop once dail

Sponsors

Santen Pharmaceutical Co Ltd
Lead Sponsor
Covance India Pharmaceutical Services Private Limited
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with open angle glaucoma or ocular hypertension in both eyes.

Exclusion criteria

Exclusion criteria: 1. Patients at risk of progression of visual field loss 2. Patients with severe visual field defect 3. Patients with any diseases that preclude participation in this study for safety reasons

Design outcomes

Primary

MeasureTime frame
Mean diurnal intraocular pressureTimepoint: 3 months

Secondary

MeasureTime frame
-Timepoint: -

Countries

India, Republic of Korea, Singapore, Taiwan

Contacts

Public ContactDr Sanish Davis

Covance India Pharmaceutical Services Private Limited

Sanish.Davis@covance.com91-7506653426

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026