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



Status:Completed
Conditions:High Blood Pressure (Hypertension), Ocular
Therapuetic Areas:Cardiology / Vascular Diseases, Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:2/7/2015
Start Date:June 2014
End Date:January 2015
Contact:Lindsey Dial
Email:ldial@santeninc.com
Phone:415-268-9063

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The purpose of this study is to investigate the safety and efficacy of five concentrations
of DE-117 ophthalmic solution.

This is a 90-day randomized, observer-masked, active-controlled, parallel-group,
multi-center, study assessing the safety and efficacy of five concentrations of DE-117
ophthalmic solution when compared to latanoprost (0.005% latanoprost) in subjects with
primary open-angle glaucoma or ocular hypertension.

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

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
We found this trial at
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Highpoint, North Carolina 27262
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Newport Beach, California 92660
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