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)
Enter a location and click search to find clinical trials sorted by distance.
1
UNMC Department of Ophthalmolgy and Visual Sciences
Omaha, Nebraska, United States, 68198-5540