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Comparison of Latanoprost Vs. Timolol

2014-08-27 03:34:18 | BioPortfolio

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.

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 controls. These changes are the cause of the elevated intraocular pressure (IOP). Aqueous flow rate did not change in these patients. It is logical to assume that it would be more efficacious to treat OHT patients with drugs that reduce IOP by increasing uveoscleral outflow (which is abnormally low) than with drugs that reduce aqueous flow (which is normal in OHT).

The primary purpose of this study is to show, through a controlled masked clinical study of OHT patients, that latanoprost increases the low uveoscleral drainage of aqueous humor (Fu) back to normal levels, and timolol maleate reduces the formation of aqueous humor (Fa) below normal. Both of these mechanisms will effectively reduce IOP.

The secondary purpose is to assess the effects of both latanoprost and timolol maleate on the fluorophotometric outflow facility (Cflu), and episcleral venous pressure (Pev) and on all parameters over time.

Subjects eligible to participate will be at least 19 years of age and diagnosed with bilateral ocular hypertension or primary open angle glaucoma and have intraocular pressure between 20 and 35 mmHg in both eyes on Day 0. Subjects will be treated with either latanoprost or timolol for 6 weeks and then crossover and be treated similarly with the alternate drug for an additional 6 weeks. There will be a screening visit and a total of 6 study visits in which aqueous humor flow, uveoscleral outflow, and fluorophotometric outflow facility will be determined using an instrument called a fluorophotometer. The fluorophotometer scans the eye for fluorescein dye allowing the investigator to measure and calculate the above variables. There will be 7 scans taken during each study day and additionally IOP will be measured after the completion of each scan. An Exit exam will be performed at the time of exit to ensure the ocular health of the subject.

Subjects will be monitored for adverse events throughout the course of the study and subjects may discontinue from the study at any time for any reason, or may be discontinued if, in the opinion of the investigator, there is a risk to the subject.

Study Design

Allocation: Randomized, Control: Placebo Control, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Conditions

Glaucoma

Intervention

Latanoprost, Timolol

Location

UNMC Department of Ophthalmolgy and Visual Sciences
Omaha
Nebraska
United States
68198-5540

Status

Completed

Source

University of Nebraska

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:34:18-0400

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A Study of Glaucoma or Ocular Hypertension in Patients Within the United States

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PubMed Articles [21 Associated PubMed Articles listed on BioPortfolio]

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To compare the additive effects and safety of 1% brinzolamide/0.5% timolol fixed combination (BTFC) versus the low-dose regimen of 1% dorzolamide/0.5% timolol fixed combination (DTFC) in patients with...

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Most pure glaucoma drugs (pGDs) are hydrophobic substances intended to reduce elevated intraocular pressure. The aims of our study were to determine the toxicity of pGDs (brimonidine tartrate, brinzol...

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The discovery of beta-adrenergic blocker effects on infantile hemangiomas has affected the choice of treatment in recent years. Oral propranolol is effective in treating infantile hemangiomas, but the...

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Medical and Biotech [MESH] Definitions

A pharmaceutical preparation of brimonidine tartrate and timolol maleate. The combined ADRENERGIC ALPHA2 RECEPTOR AGONIST and ADRENERGIC BETA-ANTAGONIST activity of these drugs reduce INTRAOCULAR PRESSURE in GLAUCOMA patients.

A beta-adrenergic antagonist similar in action to PROPRANOLOL. The levo-isomer is the more active. Timolol has been proposed as an antihypertensive, antiarrhythmic, antiangina, and antiglaucoma agent. It is also used in the treatment of MIGRAINE DISORDERS and tremor.

A cloprostenol derivative that is used as an ANTIHYPERTENSIVE AGENT in the treatment of OPEN-ANGLE GLAUCOMA and OCULAR HYPERTENSION.

A cloprostenol-derived amide that is used as an ANTIHYPERTENSIVE AGENT in the treatment of OPEN-ANGLE GLAUCOMA and OCULAR HYPERTENSION.

A quinoxaline derivative and ADRENERGIC ALHPA-2 RECEPTOR AGONIST that is used to manage INTRAOCULAR PRESSURE associated with OPEN-ANGLE GLAUCOMA and OCULAR HYPERTENSION.

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