Clinical trial NCT01654484: A Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution in Patients With POAG or OHT
Official title: A Phase I/II, Randomized, Observer-masked, Placebo-and Active-controlled, Parallel-group, Multi-center Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Glaucoma and Ocular Hypertension
Lead sponsor: Santen Inc.
Sponsor class: INDUSTRY
First posted: 2012-07-31
Enrollment: 60
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 up to three concentrations of DE-117 ophthalmic solution (Low Dose, Medium Dose, and High Dose) as monotherapy and as adjunctive therapy (DE-117 ophthalmic solution with 0.0015% tafluprost) in subjects with primary open-angle glaucoma or ocular hypertension.

Detailed description: This is a two stage study.

Stage One will explore the dose response of three concentrations of DE-117 as monotherapy compared with 0.0015% tafluprost and placebo. The safety and efficacy of DE-117 as adjunctive therapy (with 0.0015% tafluprost) compared with 0.0015% tafluprost and placebo will also be evaluated. In addition, the additive effect of adjunctive therapy of each concentration will be compared with the corresponding monotherapy concentration.

Stage Two will assess the safety and efficacy of the optimal DE-117 concentration as monotherapy compared with 0.0015% tafluprost. The safety and efficacy of the optimal DE-117 concentration as adjunctive therapy (with 0.0015% tafluprost) compared with DE-117 monotherapy and 0.0015% tafluprost will also be evaluated.

Eligibility criteria: Inclusion Criteria:

1. Male or Female, 18 years of age or older
2. Current diagnosis of primary open-angle glaucoma or ocular hypertension in both eyes
3. Qualifying intraocular pressure (IOP) in at least one eye at Baseline

Exclusion Criteria:

1. Closed/barely open anterior chamber angle or a history of acute angle closure in either eye
2. Anticipate the need to initiate or modify medication (systemic or topical) that is known to affect intraocular pressure (IOP) during the study period
3. Females who are pregnant, nursing or planning a pregnancy
4. Presence of any abnormality or significant illness that could be expected to interfere with the study.

Primary outcomes:
measure: Change from baseline in intraocular pressure (IOP) on Day 29 at each scheduled time point
timeFrame: Day 28 T0 (08:00 ±30 mins), T0+2 hrs, T0+4 hrs, T0+8 hrs
Secondary outcomes:
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Santen Investigational Site
state: California
city: Deerfield Beach
country: United States
facility: Santen Investigational Site
state: Florida
city: Largo
country: United States
facility: Santen Investigational Site
state: Florida
city: Morrow
country: United States
facility: Santen Investigational Site
state: Georgia
city: Roswell
country: United States
facility: Santen Investigational Site
state: Georgia
city: Rochester
country: United States
facility: Santen Investigational Site
state: New York
city: Cleveland
country: United States
facility: Santen Investigational Site
state: Ohio
city: Austin
country: United States
facility: Santen Investigational Site
state: Texas
city: Fort Worth
country: United States
facility: Santen Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Santen Investigational Site
state: Texas
Study officials:
References: