Study of Medical Treatment of Low-Pressure (Normal Tension) Glaucoma

Completed · Phase 2

Conditions studied: Glaucoma, Open Angle

In brief

Low-pressure (normal tension) glaucoma is a type of open-angle glaucoma resulting in damage to the optic nerve and abnormalities of the visual field. Eye (intraocular) pressure in this type of glaucoma is not higher than that usually considered to be normal (less than 21 mmHg) for the eye. The present treatment of low-pressure glaucoma is also directed to lowering the "normal" eye pressure. Both medications in this study, brimonidine and timolol, lower eye pressure. Laboratory research over the past decade indicates the potential to treat glaucoma not only by lowering eye pressure, but with treatments aimed at the damage occurring at the optic nerve. One group of drugs, selective alpha2-adrenergic agonists, have been shown in laboratory animals to protect against the effects of nerve damage following local stroke. Brimonidine, one of the medications in the current study, is a selective alpha2-adrenergic agonist which protects against damage to optic nerve in animal models of glaucoma.. The hypothesis of the present study is that brimonidine eye drops provide protection to the damaged optic nerve independent of lowering eye pressure in patients with low-pressure glaucoma. This will be determined by (1) measuring eye pressure, (2) performing visual field examinations, and (3) examination of the optic nerve.

Key facts

Study ID

NCT00317577

Run by

Chicago Center for Vision Research

People needed

160

Starts

1998-12-01

Expected to finish

2004-05-01

Last updated by the study team

2006-04-25

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age: 30 years or older.
• Low-pressure glaucoma in at least one eye: untreated IOP < 21 mmHg, glaucomatous field loss on Humphrey 24-2 perimetry, and optic disc cupping.
• Best corrected visual acuity at least 20/40 in at least one eye.
• At least two visual fields within the 6 months prior to enrollment.
• Phakic or pseudophakic (cataract surgery > one year to enrollment) eye.

You may not qualify if…

• Either eye patient exclusion:
• Past history of confirmed treated or untreated applanation IOP > 21 mmHg.
• Untreated IOP of > 21 mmHg on diurnal curve on Study Day 0.
• Untreated IOP > 4 mmHg difference between the two eyes.
• Extensive field damage: MD > 15 dB or threat fixation in both hemi fields.
• Evidence of exfoliation or pigment dispersion.
• History of angle-closure or occludable gonioscopic anterior chamber angle.
• Prior filtration surgery.
• Prior laser iridotomy.
• Laser trabeculoplasty < 6 months prior enrollment or for an IOP > 21 mmHg.
• History of chronic inflammatory eye diseases (e.g., scleritis, uveitis).
• History or signs of intraocular trauma.
• Severe or potentially progressive retinal disease.
• Any abnormality preventing reliable applanation tonometry.
• History of hypersensitivity to study medications or their components.
• Current use of any ophthalmic, dermatologic or systemic steroid preparation.
• Therapy with another investigational agent within the past 30 days.
• Single eye exclusion:
• Cataract surgery within the past year.
• Aphakia.
• Only sighted eye.
• Concomitant conditions:
• Resting pulse < 50 beats per minute.
• Unstable or uncontrolled cardiovascular, renal, or pulmonary disease.
• Recent heart attack or stroke.

Where it is running

• Little Rock Eye Clinic — Little Rock, Arkansas, United States
• University of Florida — Gainesville, Florida, United States
• Bascom Palmer Eye Institute — Palm Beach Gardens, Florida, United States
• University Eye Specialists — Chicago, Illinois, United States
• University of Chicago — Chicago, Illinois, United States
• Wheaton Eye Clinic — Wheaton, Illinois, United States
• Indiana University — Indianapolis, Indiana, United States
• New York Eye & Ear Infirmary — New York, New York, United States
• Scheie Eye Institute University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Wills Eye Hospital — Philadelphia, Pennsylvania, United States
• Black Hills Regional Eye Institute — Rapid City, South Dakota, United States
• Cullen Eye Institute Baylor University — Houston, Texas, United States

Full record on ClinicalTrials.gov

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