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
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
28
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721 Long Point Road
Mount Pleasant, South Carolina 29464
Mount Pleasant, South Carolina 29464
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