Glaucoma and Ocular Hypertension Clinical Trial
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
Verified date | April 2018 |
Source | Santen Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | November 2012 |
Est. primary completion date | November 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Santen Investigational Site | Austin | Texas |
United States | Santen Investigational Site | Cleveland | Ohio |
United States | Santen Investigational Site | Deerfield Beach | Florida |
United States | Santen Investigational Site | Fort Worth | Texas |
United States | Santen Investigational Site | Largo | Florida |
United States | Santen Investigational Site | Morrow | Georgia |
United States | Santen Investigational Site | Newport Beach | California |
United States | Santen Investigational Site | Rochester | New York |
United States | Santen Investigational Site | Roswell | Georgia |
United States | Santen Investigational Site | San Antonio | Texas |
Lead Sponsor | Collaborator |
---|---|
Santen Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in intraocular pressure (IOP) on Day 29 at each scheduled time point | Day 28 T0 (08:00 ±30 mins), T0+2 hrs, T0+4 hrs, T0+8 hrs |
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