Status:
COMPLETED
Multi-center Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension
Lead Sponsor:
Santen Inc.
Conditions:
Open-angle Glaucoma or Ocular Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to investigate the safety and efficacy of four concentrations of DE-117 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 solut...
Eligibility Criteria
Inclusion
- Main
- 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
- 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
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT01868126
Start Date
May 1 2013
End Date
September 1 2013
Last Update
April 18 2018
Active Locations (7)
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1
Newport Beach, California, United States, 92663
2
Morrow, Georgia, United States, 30260
3
Kansas City, Missouri, United States, 64133
4
Rochester, New York, United States, 14618