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 | Crick

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

370

Conditions

Open Angle Glaucoma or Ocular Hypertension

Interventions

DE-117DRUG

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

Latanoprost ophthalmic solutionDRUG

Latanoprost ophthalmic solution will be taken one drop, once daily for 3 months in both eyes.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Singapore, Singapore

Outcomes

Primary Outcomes

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.

Time frame: Month 3 (average of IOP at 3 time points: 09:00, 13:00, 17:00)

Secondary Outcomes

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.

Time frame: 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)

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.

Time frame: Week 1