DE-117 Spectrum 5 Study

Status:	Recruiting
Conditions:	High Blood Pressure (Hypertension), Ocular
Therapuetic Areas:	Cardiology / Vascular Diseases, Ophthalmology
Healthy:	No
Age Range:	18 - Any
Updated:	2/14/2019
Start Date:	September 27, 2018
End Date:	November 30, 2019
Contact:	Santen Inc Clinical Operations
Email:	clinicaltrials@santen.com
Phone:	415-268-9052

An Open-Label, Multicenter Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution 0.002% in Latanoprost Low/Non-Responder Subjects Diagnosed With Primary Open-Angle Glaucoma or Ocular Hypertension - Spectrum 5 Study

Santen will evaluate the intraocular pressure (IOP) lowering effect and efficacy of DE-117
ophthalmic solution 0.002% in latanoprost/non-responder subjects diagnosed with POAG or OHT

Inclusion Criteria:

- Patients with Primary Open-Angle Glaucoma or Ocular Hypertension in one or both eyes.

- Provide signed written informed consent.

- Diagnosis of POAG or OHT in both eyes.

- Qualifying corrected visual acuity in each eye.

- Qualifying central corneal thickness in each eye.

- Qualifying Day 1 IOP measurement at 3 time-points in both eyes after latanoprost
Run-in Period.

- Qualifying Anterior chamber angle.

Exclusion Criteria:

- Patients who cannot safely discontinue use of Ocular Hypotensive Medications during
Washout.

- Patients with prior exposure to DE-117.

- History of ocular surgery specifically intended to lower IOP

- Advanced glaucoma in either eye.

- Any corneal abnormality or other condition interfering with or preventing reliable
Goldmann applanation tonometry.

- Any ocular surgery or ocular laser treatment within 180 days prior to Visit 1
(Screening) and throughout the study in either eye.

- Females who are pregnant, nursing, or planning a pregnancy.

We found this trial at

sites

Tekwani Vision Center

9911 Kennerly Road
Saint Louis, Missouri 63128

1045

from 02139

Saint Louis, MO