DE-117 Spectrum 5 Study

Phase 3

Completed

• Conditions: Primary Open-angle Glaucoma and Ocular Hypertension
• Interventions: Drug: DE-117 Ophthalmic Solution

• Registration Number: NCT03697811
• Lead Sponsor: Santen Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-27
• Study First Submitted: 2018-10-03
• Study First Submitted QC: 2018-10-03
• Study First Posted: 2018-10-05
• Primary Completion: 2022-01-13
• Study Completion: 2022-01-13
• Results First Submitted: 2023-06-28
• Status Verified: 2023-08
• Results First Submitted QC: 2023-08-08
• Last Update Submitted: 2023-08-08
• Results First Posted: 2023-08-30
• Last Update Posted: 2023-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DE-117 Ophthalmic Solution 0.002%	DE-117 Ophthalmic Solution	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in IOP at Timepoints at Week 2	08:00, 12:00 and 16:00 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).
Change From Baseline in Mean Diurnal IOP at Week 2 and Week 6	week 2 and 6	Change from baseline (Visit 4) in mean diurnal IOP at Week 2 (Visit 5) and Week 6 (Visit 6).
Intraocular Pressure: Percent Change From Baseline by Analysis Visit and Timepoint at Month 3	08:00, 12:00 and 16:00 at month 3.	Intraocular Pressure: Percent Change from Baseline by Analysis Visit and Timepoint.
Percent Change From Baseline in Mean Diurnal IOP at Week 2, Week 6 and Month 3	week 2, 6 and month 3	The secondary efficacy endpoint evaluated percent change from baseline in mean DIOP at week 2, 6 and month 3.
Change From Baseline in IOP at Timepoints at Week 6	08:00, 12:00 and 16:00 at Week 6	Change in mean IOP were evaluated at each time point at all post-baseline visits.
Intraocular Pressure: Percent Change From Baseline by Analysis Visit and Timepoint at Week 6	08:00, 12:00 and 16:00 at week 6	Intraocular Pressure: Percent Change from Baseline by Analysis Visit and Timepoint.
Change From Baseline in IOP at Timepoints at Month 3	08:00, 12:00 and 16:00 at month 3	Change in mean IOP were evaluated at each time point at all post-baseline visits.
Intraocular Pressure: Percent Change From Baseline by Analysis Visit and Timepoint at Week 2	08:00, 12:00 and 16:00 at week 2	Intraocular Pressure: Percent Change from Baseline by Analysis Visit and Timepoint.

Trial Locations

Locations (32)

Arizona Eye Center; 🇺🇸 Chandler, Arizona, United States

Global Research Management; 🇺🇸 Glendale, California, United States

North Valley Eye Medical Group; 🇺🇸 Mission Hills, California, United States

Eye Research Foundation; 🇺🇸 Newport Beach, California, United States

North Bay Eye Associates; 🇺🇸 Petaluma, California, United States

Martel Eye Medical Group; 🇺🇸 Rancho Cordova, California, United States

Danbury Eye Physicians & Surgeons; 🇺🇸 Danbury, Connecticut, United States

Shettle Eye Research, Inc.; 🇺🇸 Largo, Florida, United States

International Eye Associates, PA; 🇺🇸 Ormond Beach, Florida, United States

Dixon Eye Care; 🇺🇸 Albany, Georgia, United States

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