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 (SEE-1)

Santen

Status and phase: Completed; Phase 2

Conditions: Open-angle Glaucoma; Ocular Hypertension

Treatments: Drug: DE-117 Low Dose ophthalmic solution; Drug: DE-117 Low/Middle Dose ophthalmic solution; Drug: latanoprost ophthalmic solution 0.005%; Drug: DE-117 Middle/High Dose ophthalmic solution; Drug: DE-117 High Dose ophthalmic solution; Drug: DE-117 Middle Dose ophthalmic solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT02179008

33-003

Details and patient eligibility

About

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

Full description

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.

Enrollment: 184 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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184 participants in 6 patient groups

DE-117 Low Dose ophthalmic solution

Experimental group

Description:

One drop Low Dose DE-117 in each eye QD for 90 days

Treatment:

Drug: DE-117 Low Dose ophthalmic solution

DE-117 Low/Middle Dose ophthalmic solution

Experimental group

Description:

One drop DE-117 Low/Middle Dose ophthalmic solution in each eye QD for 90 days

Treatment:

Drug: DE-117 Low/Middle Dose ophthalmic solution

DE-117 Middle Dose ophthalmic solution

Experimental group

Description:

One drop Middle Dose DE-117 in each eye QD for 90 days

Treatment:

Drug: DE-117 Middle Dose ophthalmic solution

DE-117 Middle/High Dose ophthalmic solution

Experimental group

Description:

One drop Middle/High Dose DE-117 in each eye QD for 90 days

Treatment:

Drug: DE-117 Middle/High Dose ophthalmic solution

DE-117 High Dose ophthalmic solution

Experimental group

Description:

One drop High Dose DE-117 in each eye QD for 90 days

Treatment:

Drug: DE-117 High Dose ophthalmic solution

latanoprost ophthalmic solution 0.005%

Active Comparator group

Description:

One drop latanaprost in each eye QD for 90 days

Treatment:

Drug: latanoprost ophthalmic solution 0.005%