Multi-center Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension

A Phase II, Randomized, Observer-masked, Placebo-and Active-controlled, Parallel-group, Multi-center Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution Compared With Latanoprost and Placebo in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension

The purpose of this study is to investigate the safety and efficacy of four concentrations of DE-117 ophthalmic solution.

Study Overview

• Status: Completed
• Conditions: Open-angle Glaucoma or Ocular Hypertension
• Intervention / Treatment: Other: Placebo; Drug: DE-117 ophthalmic solution; Drug: latanoprost ophthalmic solution

Detailed Description

This is a 28-day randomized, observer-masked, placebo-and active-controlled, parallel-group, multi-center, study investigating the safety and efficacy of four concentrations of DE-117 ophthalmic solution when compared to latanoprost (0.005% latanoprost) and placebo (vehicle of DE-117) in subjects with primary open-angle glaucoma or ocular hypertension.

• Study Type: Interventional
• Enrollment (Actual): 91
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Newport Beach, California, United States, 92663
  • Georgia
    • Morrow, Georgia, United States, 30260
  • Missouri
    • Kansas City, Missouri, United States, 64133
  • New York
    • Rochester, New York, United States, 14618
  • Ohio
    • Cleveland, Ohio, United States, 44115
  • Texas
    • Austin, Texas, United States, 78731
    • San Antonio, Texas, United States, 78240

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Main Inclusion Criteria:

• Current diagnosis of primary open-angle glaucoma or ocular hypertension in both eyes
• Qualifying intraocular pressure in at least one eye at Baseline
• Qualifying corrected ETDRS visual acuity in each eye
• Qualifying central cornea thickness in each eye

Main Exclusion Criteria:

• Closed/barely open anterior chamber angle or a history of acute angle closure in either eye
• Diagnosis of primary open-angle glaucoma or ocular hypertension due to etiology known to be non-responsive to conventional drug therapy
• Evidence of advanced glaucoma, visual field defect or progressive visual field loss that that do not meet the study criteria
• History of ocular surgery specifically intended to lower IOP
• History of any ocular or systemic abnormality or condition that may put the subject at significant risk, may confound study results, or may interfere significantly with the subject's participation in the study
• Intended or current use of any ocular medications other than study medications during the study
• Use of contact lenses within one week prior to Baseline (Day 1) until end of treatment
• Known allergy or sensitivity to any components of the study medications
• Use of steroids (systemic) within 30 days prior to Visit 1 (Screening)
• Anticipate the need to initiate or modify an existing chronic therapy that could substantially affect IOP or the study outcomes during the study period
• Females who are pregnant, nursing or planning a pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: DE-117 ophthalmic solution; One drop DE-117 Low Dose in each eye daily for 28 days	Drug: DE-117 ophthalmic solution
Experimental: Group 2: DE-117 ophthalmic solution; One drop DE-117 Low Middle Dose in each eye daily for 28 days	Drug: DE-117 ophthalmic solution
Experimental: Group 3: DE-117 ophthalmic solution; One drop DE-117 High Middle Dose in each eye daily for 28 days	Drug: DE-117 ophthalmic solution
Experimental: Group 4: DE-117 ophthalmic solution; One drop DE-117 High Dose in each eye daily for 28 days	Drug: DE-117 ophthalmic solution
Active Comparator: latanoprost ophthalmic solution; One drop latanoprost 0.005% in each eye daily for 28 days	Drug: latanoprost ophthalmic solution
Placebo Comparator: placebo (vehicle of DE-117) ophthalmic solution; One drop DE-117 vehicle in each eye once daily for 28 days	Other: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraocular pressure (mmHg)	Intraocular pressure (mmHg) measurements will be collected at each visit using Goldmann applanation tonometry	Day 1, Day 8, Day 15 and Day 29

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Adverse events will be assessed at each visit to evaluate safety	Day 1, Day 8, Day 15 and Day 29
Ocular signs and symptoms	Ocular symptoms and ocular signs will be collected at each visit using slit lamp biomicroscopy, dilated ophthalmoscopy, gonioscopy, automated perimetry visual field testing, corrected visual acuity and pachymetry	Day 1, Day 8, Day 15 and Day 29

Collaborators and Investigators

• Sponsor: Santen Inc.

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: May 29, 2013
• First Submitted That Met QC Criteria: May 29, 2013
• First Posted (Estimate): June 4, 2013

Study Record Updates

• Last Update Posted (Actual): April 18, 2018
• Last Update Submitted That Met QC Criteria: April 16, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Ocular hypertension; Eye; Glaucoma; Santen
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Ophthalmic Solutions; Pharmaceutical Solutions; Latanoprost
• Other Study ID Numbers: 33-002