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Clinical trial

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

ID
Name
011711IN
Description
Santen will evaluate the intraocular pressure (IOP) lowering effect and efficacy of DE-117 ophthalmic solution 0.002% in latanoprost low/non-responder subjects diagnosed with POAG or OHT
Trial arms
Trial start
2018-09-27
Estimated PCD
2022-01-13
Trial end
2022-01-13
Status
Completed
Phase
Early phase I
Treatment
DE-117 Ophthalmic Solution
Interventional treatment will be made with DE-117 Ophthalmic Solution 0.002% once daily in the evening for the duration of the 3 month treatment period.
Arms:
DE-117 Ophthalmic Solution 0.002%
Size
107
Primary endpoint
Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Month 3.
Month 3
Eligibility criteria
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. * Qualifying IOP measurement at 3 time-points during latanoprost Run-in Period. 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 107, 'type': 'ACTUAL'}}
Updated at
2023-08-30

1 organization

1 product

1 indication

Organization
Santen
Product
DE-117
Indication
Primary Open-angle Glaucoma