Multi-center Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension

Santen

Status and phase: Completed; Phase 2

Conditions: Open-angle Glaucoma or Ocular Hypertension

Treatments: Other: Placebo; Drug: latanoprost ophthalmic solution; Drug: DE-117 ophthalmic solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT01868126

33-002

Details and patient eligibility

About

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

Full description

This is a 28-day randomized, observer-masked, placebo-and active-controlled, parallel-group, multi-center, study investigating the safety and efficacy of four concentrations of DE-117 ophthalmic solution when compared to latanoprost (0.005% latanoprost) and placebo (vehicle of DE-117) in subjects with primary open-angle glaucoma or ocular hypertension.

Enrollment: 91 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Main 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

Main 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: Single Blind

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91 participants in 6 patient groups, including a placebo group

Group 1: DE-117 ophthalmic solution

Experimental group

Description:

One drop DE-117 Low Dose in each eye daily for 28 days

Treatment:

Drug: DE-117 ophthalmic solution

Group 2: DE-117 ophthalmic solution

Experimental group

Description:

One drop DE-117 Low Middle Dose in each eye daily for 28 days

Treatment:

Drug: DE-117 ophthalmic solution

Group 3: DE-117 ophthalmic solution

Experimental group

Description:

One drop DE-117 High Middle Dose in each eye daily for 28 days

Treatment:

Drug: DE-117 ophthalmic solution

Group 4: DE-117 ophthalmic solution

Experimental group

Description:

One drop DE-117 High Dose in each eye daily for 28 days

Treatment:

Drug: DE-117 ophthalmic solution

latanoprost ophthalmic solution

Active Comparator group

Description:

One drop latanoprost 0.005% in each eye daily for 28 days

Treatment:

Drug: latanoprost ophthalmic solution

placebo (vehicle of DE-117) ophthalmic solution

Placebo Comparator group

Description:

One drop DE-117 vehicle in each eye once daily for 28 days

Treatment:

Other: Placebo