Status:

TERMINATED

Comparison of Latanoprost Vs. Timolol

Lead Sponsor:

University of Nebraska

Conditions:

Glaucoma

Eligibility:

All Genders

19+ years

Phase:

PHASE2

Brief Summary

The primary purpose of this study is to show, through a controlled masked clinical study of subjects with ocular hypertension (OHT), that latanoprost increases the low uveoscleral drainage of aqueous ...

Detailed Description

A recent publication by our laboratory has shown that patients with ocular hypertension (OHT) have reduced uveoscleral outflow and reduced trabecular outflow facility compared with healthy age-matched...

Eligibility Criteria

Inclusion Criteria:

  • Minimum of nineteen (19) years of age.
  • Diagnosed with bilateral ocular hypertension or primary open angle glaucoma for at least six months prior to screen visit.
  • IOP of 20-35 mmHg in both eyes and not more than 5 mmHg difference between eyes at the Baseline 0800 ±1 hour IOP measurement.
  • Willing and able to provide informed consent.
  • Able to adhere to treatment/visit plan.

Exclusion Criteria:

Systemic Conditions:

  • History of severe, unstable or uncontrolled cardiovascular, hepatic or renal disease.
  • History of bronchial asthma or chronic obstructive pulmonary disease.
  • Allergies to sulfa drugs.

Ocular Conditions:

  • Chronic or recurrent severe ocular inflammatory disease.
  • Ocular infection or inflammation within three (3) months of the study visit.
  • Subjects currently treated with more than two ocular hypotensive medications.
  • Subjects having previous exposure to: adrenergic antagonists, topical prostaglandin analogues (including latanoprost, unoprostone, travoprost and bimatoprost) within four (4) weeks of the baseline visit; adrenergic agonists within two (2) weeks of the baseline visit; and cholinergic agonists and carbonic anhydrase inhibitors within five (5) days of the baseline visit.
  • History of any severe ocular pathology that would preclude the administration of a topical prostaglandin or beta-blocker.
  • History of severe or serious hypersensitivity to topical or systemic prostaglandins or beta-blockers.
  • Intraocular pressures less than 20 mmHg when off all ocular medications.
  • Cornea thickness greater than 600 microns.

Women:

  • Women of childbearing potential who are sexually active, or plan to become sexually active, and don't have a vasectomized partner, must agree to use at least one of the following acceptable contraceptive methods: condoms (male or female with or without a spermicidal agent, a diaphragm or cervical cap with spermicide, an intrauterine device (IUD) or hormonal-based contraception. Women of childbearing potential are defined as women who are not surgically sterile or not postmenopausal (at least 12 months without menstrual period).
  • Nursing mothers.
  • Pregnancy
  • General
  • Subjects less than nineteen (19) years of age.
  • Therapy with another investigational agent within 30 days of Screening Visit.

Key Trial Info

Start Date :

December 1 2003

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 1 2008

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT00579969

Start Date

December 1 2003

End Date

October 1 2008

Last Update

December 21 2023

Active Locations (1)

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Page 1 of 1 (1 locations)

1

UNMC Department of Ophthalmolgy and Visual Sciences

Omaha, Nebraska, United States, 68198-5540