Clinical trial NCT01868126: Multi-center Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Open-angle Glaucoma or Ocular Hypertension
Keywords: Santen
Eye
Glaucoma
Ocular hypertension
Lead sponsor: Santen Inc.
Sponsor class: INDUSTRY
First posted: 2013-06-04
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 solution when compared to latanoprost (0.005% latanoprost) and placebo (vehicle of DE-117) in subjects with primary open-angle glaucoma or ocular hypertension.

Eligibility criteria: 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

Primary outcomes:
measure: Intraocular pressure (mmHg)
timeFrame: Day 1, Day 8, Day 15 and Day 29
Secondary outcomes:
measure: Adverse events
timeFrame: Day 1, Day 8, Day 15 and Day 29
measure: Ocular signs and symptoms
timeFrame: Day 1, Day 8, Day 15 and Day 29
Other outcomes:
Locations:
city: Newport Beach
country: United States
state: California
city: Morrow
country: United States
state: Georgia
city: Kansas City
country: United States
state: Missouri
city: Rochester
country: United States
state: New York
city: Cleveland
country: United States
state: Ohio
city: Austin
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
Study officials:
References: