Glaucoma, Open Angle Clinical Trial
Official title:
A Multicenter, Double-Masked, 2-Arm Parallel Group Study Comparing the Effect of Brimonidine 0.2% Versus Timolol 0.5% on Visual Field Stability in Patients With Low-Pressure Glaucoma
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.
Status | Completed |
Enrollment | 160 |
Est. completion date | May 2004 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 30 Years and older |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: 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. - Women contemplating pregnancy, who are pregnant or are a nursing mother. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University Eye Specialists | Chicago | Illinois |
United States | University of Chicago | Chicago | Illinois |
United States | University of Florida | Gainesville | Florida |
United States | Cullen Eye Institute Baylor University | Houston | Texas |
United States | Indiana University | Indianapolis | Indiana |
United States | Little Rock Eye Clinic | Little Rock | Arkansas |
United States | New York Eye & Ear Infirmary | New York | New York |
United States | Bascom Palmer Eye Institute | Palm Beach Gardens | Florida |
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 | Wheaton Eye Clinic | Wheaton | Illinois |
Lead Sponsor | Collaborator |
---|---|
Chicago Center for Vision Research |
United States,
Krupin T, Liebmann JM, Greenfield DS, Rosenberg LF, Ritch R, Yang JW; Low-Pressure Glaucoma Study Group. The Low-pressure Glaucoma Treatment Study (LoGTS) study design and baseline characteristics of enrolled patients. Ophthalmology. 2005 Mar;112(3):376-85. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To compare changes in automated static visual field decibel values at 4 month intervals over 4 years of monotherapy with either brimonidine or timolol eye drops. | |||
Secondary | To characterize the intraocular pressure throughout the study period. | |||
Secondary | To characterize optic disc changes (e.g., cupping and disc hemorrhages) over the 4 years of treatment with brimonidine or timolol. | |||
Secondary | To follow the safety parameters throughout the study period. | |||
Secondary | To determine risk factors for visual field progression in low-pressure glaucoma |
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