Comparison of Latanoprost Vs. Timolol

NCT00579969 | Terminated Phase 2

• 1 other identifier: 0335-03-XX
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 humor back to normal levels, and timolol maleate reduces the formation of aqueous humor below normal. Both of these mechanisms will effectively reduce intraocular pressure (IOP). The secondary purpose is to assess the effects of both latanoprost and timolol maleate on the fluorophotometric outflow facility, and episcleral venous pressure and on all parameters over time.

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

• Comparison of Latanoprost and Timolol in lowering ocular pressure

  Two drugs, Latanoprost and Timolol, will be compared in ocular hypertensive patients in their ability to lower ocular pressure at six months using a Goldmann applanation tonometer (GAT).

  6 months

Study Arms (2)

Latanoprost Effects on Aqueous Humor Dynamics in Ocular Hypertensive Patients

EXPERIMENTAL

Evaluating the Effects of Latanoprost on Aqueous Humor Dynamics in Ocular Hypertensive Patients (prostaglandin analogue)

Drug: Latanoprost

Timolol Effects on Aqueous Humor Dynamics in Ocular Hypertensive Patients

EXPERIMENTAL

Evaluating the Effects of Timolol on Aqueous Humor Dynamics in Ocular Hypertensive Patients (prostaglandin analogue)

Drug: Timolol

Interventions

Latanoprost DRUG

dosage form:eye drops, dosage: One drop in each eye twice a day

Latanoprost Effects on Aqueous Humor Dynamics in Ocular Hypertensive Patients

Timolol DRUG

dosage form:eye drops, dosage: One drop in each eye twice a day

Timolol Effects on Aqueous Humor Dynamics in Ocular Hypertensive Patients

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

UNMC Department of Ophthalmolgy and Visual Sciences

Omaha, Nebraska, 68198-5540, United States

Location

MeSH Terms

Conditions

Glaucoma

Interventions

Latanoprost; Timolol

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morpholines; Oxazines

Study Officials

• Carl B Camras, MD

  UNMC Department of Ophthalmology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2007
• First Posted: December 24, 2007
• Study Start: December 1, 2003
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: December 21, 2023

Record last verified: 2023-12

Locations

US (1)