Phase 1-2 Evaluation of OT-730 Eye Drops in Reducing the Intraocular Pressure in Patients With Ocular Hypertension or Open-Angle Glaucoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00753168
Recruitment Status : Completed
First Posted : September 16, 2008
Last Update Posted : January 7, 2009
Information provided by:
Othera Pharmaceuticals

Brief Summary:
The purpose of this study is to evaluate the safety and potential efficacy of a new drug, OT-730 ophthalmic solution (eye drops), in reducing intraocular pressure in the eyes of patients with open angle glaucoma or ocular hypertension. It will be compared with commercial timolol and placebo eye drops.

Condition or disease Intervention/treatment Phase
Glaucoma, Open-Angle Ocular Hypertension Drug: OT-730 ophthalmic solution Drug: timolol maleate ophthalmic solution Drug: OT-730 placebo Phase 1 Phase 2

Detailed Description:

Glaucoma is a group of diseases of the eye that can result in irreversible vision loss due to damage to the optic nerve. Elevated intraocular pressure (IOP) is one factor associated with glaucoma. Currently-available medication used to lower IOP includes beta-blocking agents, which can have undesirable side effects on the cardiac and respiratory systems.

The OT-730 ophthalmic solution contains OT-730, a prodrug that, when applied as an eyedrop, metabolizes to OT-705, an active beta blocker. The OT-730 ophthalmic solution is being studied to see how well it lowers IOP in patients with a diagnosis of open angle glaucoma or ocular hypertension. It will be compared with a well known beta blocker, timolol maleate ophthalmic solution, and with a placebo eye drop, in order to assess its ability to lower IOP without the typical side effects of other beta blockers.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Parallel-Group, Multi-Center, Investigator-Masked, Active-and Placebo-Controlled, Phase 1-2 Evaluation of the Safety and Efficacy of OT-730 Ophthalmic Solution in Reducing the Intraocular Pressure in Subjects With Ocular Hypertension or Open-Angle Glaucoma
Study Start Date : September 2008
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
OT-730 ophthalmic solution
Drug: OT-730 ophthalmic solution
one eye drop twice daily
Active Comparator: 2
timolol maleate ophthalmic solution
Drug: timolol maleate ophthalmic solution
one eye drop twice daily
Placebo Comparator: 3
placebo eye drops
Drug: OT-730 placebo
one eye drop twice daily

Primary Outcome Measures :
  1. Assess the safety profile of OT-730 [ Time Frame: 8 days ]
  2. Change from baseline in intraocular pressure [ Time Frame: Day 6 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • healthy subjects, 18 to 80 years of age, any gender
  • diagnosis of primary open angle, pseudoexfoliative or pigmentary glaucoma or ocular hypertension

Exclusion Criteria:

  • have VA worse than 20/200,
  • cataract that compromises visualization of fundus,
  • history of lack of response to ocular beta blocker therapy,
  • uncontrolled intraocular pressure,
  • angle closure glaucoma or occludable angles,
  • retinal detachment, macular hole, progressive vision loss, any progressive retinal disease or neurologic disease other than glaucoma that is likely to worsen visual field or acuity during the course of the study,
  • a history of, or any current condition contraindicated with use of a beta blocker (e.g., chronic obstructive pulmonary disease, bronchial asthma, congestive heart failure, myasthenia gravis, hypoglycemia, bradycardia, etc),
  • chronic use of steroids,
  • any disease that, in the opinion of the investigator, may put the patient at significant risk,
  • taking systemic beta blockers

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00753168

United States, California
Artesia, California, United States
United States, Georgia
Roswell, Georgia, United States
United States, North Carolina
Charlotte, North Carolina, United States
High Point, North Carolina, United States
United States, South Carolina
Mount Pleasant, South Carolina, United States
Sponsors and Collaborators
Othera Pharmaceuticals

Responsible Party: Alison Brown, Othera Pharmaceuticals, Inc. Identifier: NCT00753168     History of Changes
Other Study ID Numbers: OT-730-C01
First Posted: September 16, 2008    Key Record Dates
Last Update Posted: January 7, 2009
Last Verified: January 2009

Keywords provided by Othera Pharmaceuticals:
glaucoma, open angle, ocular hypertension, beta blocker, beta adrenergic, intraocular pressure

Additional relevant MeSH terms:
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Maleic acid
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Antihypertensive Agents
Enzyme Inhibitors