Safety and Efficacy Trial to Treat Open-Angle Glaucoma or Ocular Hypertension

Santen

Status and phase: Completed; Phase 2; Phase 1

Conditions: Open-angle Glaucoma; Ocular Hypertension

Treatments: Drug: DE-112 Vehicle Solution; Drug: Timolol Maleate Solution; Drug: DE-112

Study type: Interventional

Funder types: Industry

Identifiers

NCT01279083

29-001

Details and patient eligibility

About

To investigate the safety and efficacy of DE-112 in lowering intraocular pressure in subjects with primary open-angle glaucoma or ocular hypertension.

Full description

This study will be conducted in two stages. Stage One is an open-label, adaptive dose-selection, safety and efficacy trial of up to four concentrations of DE-112 ophthalmic solution enrolling a total of 24 subjects.

Stage Two of the study is a randomized, double-masked, placebo- and active-controlled, parallel-group, multi-center trial comparing the efficacy and safety of two concentrations of DE-112 ophthalmic solution with placebo and timolol enrolling a total of 120 subjects.

Enrollment: 147 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Provide signed, written informed consent
• 18 yeas of age and older
• Diagnosed with primary open-angle glaucoma or ocular hypertension
• Female subject of childbearing potential must utilize reliable contraceptive throughout the study and have a negative urine pregnancy test prior to enrollment into this study
• Meet specific Visit 2, Day 0 (Baseline)criteria at baseline

Exclusion criteria

• Females who are pregnant, nursing or planning a pregnancy
• Presence of any abnormality or significant illness that could be expected to interfere with the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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147 participants in 6 patient groups, including a placebo group

Concentration 1

Experimental group

Treatment:

Drug: DE-112

Drug: DE-112

Drug: DE-112

Drug: DE-112

Concentration 2

Experimental group

Treatment:

Drug: DE-112

Drug: DE-112

Drug: DE-112

Drug: DE-112

Concentration 3

Experimental group

Treatment:

Drug: DE-112

Drug: DE-112

Drug: DE-112

Drug: DE-112

Concentration 4

Experimental group

Treatment:

Drug: DE-112

Drug: DE-112

Drug: DE-112

Drug: DE-112

Vehicle Solution

Placebo Comparator group

Treatment:

Drug: DE-112 Vehicle Solution

Timolol Maleate Ophthalmic Solution

Active Comparator group

Treatment:

Drug: Timolol Maleate Solution