Safety and Efficacy Study of DE-104 Ophthalmic Solution to Treat Open-angle Glaucoma or Ocular Hypertension

Santen

Status and phase: Completed; Phase 2

Conditions: Open-Angle Glaucoma; Ocular Hypertension

Treatments: Drug: DE-104 ophthalmic solution, high concentration; Drug: DE-104 ophthalmic solution, low concentration; Drug: 0.005% latanoprost; Drug: DE-104 ophthalmic solution, medium concentration; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00650338

27-002

Details and patient eligibility

About

To investigate the dose-response relationship of DE-104 ophthalmic solution in lowering intraocular pressure (IOP) in subjects with Primary Open-Angle Glaucoma or Ocular Hypertension

Enrollment: 165 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Provided signed, written informed consent.
• Diagnosed with primary open-angle glaucoma or ocular hypertension.
• 18 years of age and older.
• If a subject is a female of childbearing potential, she must utilize reliable contraceptive throughout the study, and must have a negative urine pregnancy test prior to enrollment into this study.

Exclusion criteria

• Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception.
• 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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165 participants in 5 patient groups, including a placebo group

1

Experimental group

Description:

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Treatment:

Drug: DE-104 ophthalmic solution, low concentration

2

Experimental group

Description:

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Treatment:

Drug: DE-104 ophthalmic solution, medium concentration

3

Experimental group

Description:

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Treatment:

Drug: DE-104 ophthalmic solution, high concentration

4

Placebo Comparator group

Description:

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Treatment:

Drug: Placebo

5

Active Comparator group

Description:

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Treatment:

Drug: 0.005% latanoprost