Multi-center Phase II Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension (SEE-1)

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

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension; Open-angle Glaucoma
• Intervention / Treatment: Drug: DE-117 Low Dose ophthalmic solution; Drug: DE-117 Low/Middle Dose ophthalmic solution; Drug: DE-117 Middle Dose ophthalmic solution; Drug: DE-117 Middle/High Dose ophthalmic solution; Drug: DE-117 High Dose ophthalmic solution; Drug: latanoprost ophthalmic solution 0.005%

Detailed Description

This is a 90-day randomized, observer-masked, active-controlled, parallel-group, multi-center, study assessing the safety and efficacy of five concentrations of DE-117 ophthalmic solution when compared to latanoprost (0.005% latanoprost) in subjects with primary open-angle glaucoma or ocular hypertension.

• Study Type: Interventional
• Enrollment (Actual): 184
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Chandler, Arizona, United States, 85225
  • California
    • Artesia, California, United States, 90701
    • Glendale, California, United States, 91204
    • Long Beach, California, United States, 90806
    • Newport Beach, California, United States, 92663
  • Florida
    • Largo, Florida, United States, 33773
  • Georgia
    • Morrow, Georgia, United States, 30260
    • Roswell, Georgia, United States, 30076
  • New York
    • Rochester, New York, United States, 14618
  • North Carolina
    • High Point, North Carolina, United States, 27262
  • Ohio
    • Cleveland, Ohio, United States, 44115
  • Texas
    • Austin, Texas, United States, 78731
    • Houston, Texas, United States, 77005
    • 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

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

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: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DE-117 Low Dose ophthalmic solution; One drop Low Dose DE-117 in each eye QD for 90 days	Drug: DE-117 Low Dose ophthalmic solution; Low Dose DE-117 ophthalmic solution; Other Names: DE-117
Experimental: DE-117 Low/Middle Dose ophthalmic solution; One drop DE-117 Low/Middle Dose ophthalmic solution in each eye QD for 90 days	Drug: DE-117 Low/Middle Dose ophthalmic solution; Low/Middle Dose DE-117; Other Names: DE-117
Experimental: DE-117 Middle Dose ophthalmic solution; One drop Middle Dose DE-117 in each eye QD for 90 days	Drug: DE-117 Middle Dose ophthalmic solution; Middle Dose DE-117; Other Names: DE-117
Experimental: DE-117 Middle/High Dose ophthalmic solution; One drop Middle/High Dose DE-117 in each eye QD for 90 days	Drug: DE-117 Middle/High Dose ophthalmic solution; Middle/High Dose DE-117; Other Names: DE-117
Experimental: DE-117 High Dose ophthalmic solution; One drop High Dose DE-117 in each eye QD for 90 days	Drug: DE-117 High Dose ophthalmic solution; High Dose DE-117; Other Names: DE-117
Active Comparator: latanoprost ophthalmic solution 0.005%; One drop latanaprost in each eye QD for 90 days	Drug: latanoprost ophthalmic solution 0.005%; 0.005% latanoprost; Other Names: latanoprost

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraocular pressure (mmHg)	Intraocular pressure (mmHg) measurements will be collected using Goldmann applanation tonometry	Day 91

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects with Adverse Events as a Measure of Safety and Tolerability	Adverse events will be assessed at each visit to evaluate safety	Day 1, Day 8, Day 15, Day 31, Day 61 and Day 91

Collaborators and Investigators

• Sponsor: Santen Inc.

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: June 26, 2014
• First Submitted That Met QC Criteria: June 27, 2014
• First Posted (Estimate): July 1, 2014

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: 33-003