DE-117 Spectrum 5 Study

Santen Inc.107 enrolled

Overview

Santen will evaluate the intraocular pressure (IOP) lowering effect and efficacy of DE-117 ophthalmic solution 0.002% in latanoprost low/non-responder subjects diagnosed with POAG or OHT

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

107

Conditions

Primary Open-angle Glaucoma and Ocular Hypertension

Interventions

DE-117 Ophthalmic SolutionDRUG

Interventional treatment will be made with DE-117 Ophthalmic Solution 0.002% once daily in the evening for the duration of the 3 month treatment period.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with Primary Open-Angle Glaucoma or Ocular Hypertension in one or both eyes. * Provide signed written informed consent. * Diagnosis of POAG or OHT in both eyes. * Qualifying corrected visual acuity in each eye. * Qualifying central corneal thickness in each eye. * Qualifying Day 1 IOP measurement at 3 time-points in both eyes after latanoprost Run-in Period. * Qualifying Anterior chamber angle. * Qualifying IOP measurement at 3 time-points during latanoprost Run-in Period. Exclusion Criteria: * Patients who cannot safely discontinue use of Ocular Hypotensive Medications during Washout. * Patients with prior exposure to DE-117. * History of ocular surgery specifically intended to lower IOP * Advanced glaucoma in either eye. * Any corneal abnormality or other condition interfering with or preventing reliable Goldmann applanation tonometry. * Any ocular surgery or ocular laser treatment within 180 days prior to Visit 1 (Screening) and throughout the study in either eye. * Females who are pregnant, nursing, or planning a pregnancy.

Locations (32)

Outcomes

Primary Outcomes

Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Month 3.

IOP lowering effect of DE-117 ophthalmic solution 0.002% in Latanoprost low/non-responder subjects. Mean Diurnal Intraocular Pressure: Analysis of Change from Baseline in IOP score at Month 3 using Paired T-test on Observed Case. Mean Diurnal IOP is defined as the average IOP of all three timepoints (8:00,12:00, 16:00) at Month 3.

Time frame: Month 3

Secondary Outcomes

Percent Change From Baseline in Mean Diurnal IOP at Week 2, Week 6 and Month 3

The secondary efficacy endpoint evaluated percent change from baseline in mean DIOP at week 2, 6 and month 3.

Time frame: week 2, 6 and month 3

Change From Baseline in Mean Diurnal IOP at Week 2 and Week 6

Change from baseline (Visit 4) in mean diurnal IOP at Week 2 (Visit 5) and Week 6 (Visit 6).

Time frame: week 2 and 6

Change From Baseline in IOP at Timepoints at Week 2

Change in mean IOP were evaluated at each time point at all post-baseline visits. (Change from baseline measurement at each timepoint was calculated by deducting the baseline value at corresponding timepoint from the IOP measurement).

Time frame: 08:00, 12:00 and 16:00 at Week 2

Change From Baseline in IOP at Timepoints at Week 6

Change in mean IOP were evaluated at each time point at all post-baseline visits.

Time frame: 08:00, 12:00 and 16:00 at Week 6

Change From Baseline in IOP at Timepoints at Month 3

Change in mean IOP were evaluated at each time point at all post-baseline visits.

Time frame: 08:00, 12:00 and 16:00 at month 3

Data from ClinicalTrials.gov

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