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
1 other identifier
interventional
184
1 country
14
Brief Summary
The purpose of this study is to investigate the safety and efficacy of five concentrations of DE-117 ophthalmic solution.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2014
Shorter than P25 for phase_2
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 26, 2014
CompletedFirst Posted
Study publicly available on registry
July 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedApril 18, 2018
April 1, 2018
7 months
June 26, 2014
April 16, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Intraocular pressure (mmHg)
Intraocular pressure (mmHg) measurements will be collected using Goldmann applanation tonometry
Day 91
Secondary Outcomes (1)
Number of Subjects with Adverse Events as a Measure of Safety and Tolerability
Day 1, Day 8, Day 15, Day 31, Day 61 and Day 91
Study Arms (6)
DE-117 Low Dose ophthalmic solution
EXPERIMENTALOne drop Low Dose DE-117 in each eye QD for 90 days
DE-117 Low/Middle Dose ophthalmic solution
EXPERIMENTALOne drop DE-117 Low/Middle Dose ophthalmic solution in each eye QD for 90 days
DE-117 Middle Dose ophthalmic solution
EXPERIMENTALOne drop Middle Dose DE-117 in each eye QD for 90 days
DE-117 Middle/High Dose ophthalmic solution
EXPERIMENTALOne drop Middle/High Dose DE-117 in each eye QD for 90 days
DE-117 High Dose ophthalmic solution
EXPERIMENTALOne drop High Dose DE-117 in each eye QD for 90 days
latanoprost ophthalmic solution 0.005%
ACTIVE COMPARATOROne drop latanaprost in each eye QD for 90 days
Interventions
Low Dose DE-117 ophthalmic solution
Low/Middle Dose DE-117
Middle Dose DE-117
Middle/High Dose DE-117
High Dose DE-117
0.005% latanoprost
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Santen Inc.lead
Study Sites (14)
Unknown Facility
Chandler, Arizona, 85225, United States
Unknown Facility
Artesia, California, 90701, United States
Unknown Facility
Glendale, California, 91204, United States
Unknown Facility
Long Beach, California, 90806, United States
Unknown Facility
Newport Beach, California, 92663, United States
Unknown Facility
Largo, Florida, 33773, United States
Unknown Facility
Morrow, Georgia, 30260, United States
Unknown Facility
Roswell, Georgia, 30076, United States
Unknown Facility
Rochester, New York, 14618, United States
Unknown Facility
High Point, North Carolina, 27262, United States
Unknown Facility
Cleveland, Ohio, 44115, United States
Unknown Facility
Austin, Texas, 78731, United States
Unknown Facility
Houston, Texas, 77005, United States
Unknown Facility
San Antonio, Texas, 78240, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2014
First Posted
July 1, 2014
Study Start
June 1, 2014
Primary Completion
January 1, 2015
Study Completion
January 1, 2015
Last Updated
April 18, 2018
Record last verified: 2018-04