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

This study has been completed.
Sponsor:
Information provided by:
Othera Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00753168
First received: September 8, 2008
Last updated: January 6, 2009
Last verified: January 2009
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:


Further study details as provided by Othera Pharmaceuticals:

Primary Outcome Measures:
  • Assess the safety profile of OT-730 [ Time Frame: 8 days ] [ Designated as safety issue: Yes ]
  • Change from baseline in intraocular pressure [ Time Frame: Day 6 ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: September 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00753168

Locations
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
  More Information

Additional Information:
No publications provided

Responsible Party: Alison Brown, Othera Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00753168     History of Changes
Other Study ID Numbers: OT-730-C01
Study First Received: September 8, 2008
Last Updated: January 6, 2009
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Hypertension
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Timolol
Therapeutic Uses
Pharmacologic Actions
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Antihypertensive Agents

ClinicalTrials.gov processed this record on September 18, 2014