Study of Medical Treatment of Low-Pressure (Normal Tension) Glaucoma
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
1 other identifier
interventional
160
1 country
12
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 1998
Longer than P75 for phase_2
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 1998
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2004
CompletedFirst Submitted
Initial submission to the registry
April 23, 2006
CompletedFirst Posted
Study publicly available on registry
April 25, 2006
CompletedApril 25, 2006
April 1, 2006
April 23, 2006
April 23, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
To characterize the intraocular pressure throughout the study period.
To characterize optic disc changes (e.g., cupping and disc hemorrhages) over the 4 years of treatment with brimonidine or timolol.
To follow the safety parameters throughout the study period.
To determine risk factors for visual field progression in low-pressure glaucoma
Interventions
Eligibility Criteria
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:
- 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.
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Little Rock Eye Clinic
Little Rock, Arkansas, 72205, United States
University of Florida
Gainesville, Florida, 32610, United States
Bascom Palmer Eye Institute
Palm Beach Gardens, Florida, 33418, United States
University Eye Specialists
Chicago, Illinois, 60611, United States
University of Chicago
Chicago, Illinois, 60637, United States
Wheaton Eye Clinic
Wheaton, Illinois, 60187, United States
Indiana University
Indianapolis, Indiana, 46202, United States
New York Eye & Ear Infirmary
New York, New York, 10003, United States
Scheie Eye Institute University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Wills Eye Hospital
Philadelphia, Pennsylvania, 19107, United States
Black Hills Regional Eye Institute
Rapid City, South Dakota, 57701, United States
Cullen Eye Institute Baylor University
Houston, Texas, 77030, United States
Related Publications (4)
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. doi: 10.1016/j.ophtha.2004.10.034.
PMID: 15745762BACKGROUNDFurlanetto RL, De Moraes CG, Teng CC, Liebmann JM, Greenfield DS, Gardiner SK, Ritch R, Krupin T; Low-Pressure Glaucoma Treatment Study Group. Risk factors for optic disc hemorrhage in the low-pressure glaucoma treatment study. Am J Ophthalmol. 2014 May;157(5):945-52. doi: 10.1016/j.ajo.2014.02.009. Epub 2014 Feb 7.
PMID: 24513094DERIVEDDe Moraes CG, Liebmann JM, Greenfield DS, Gardiner SK, Ritch R, Krupin T; Low-pressure Glaucoma Treatment Study Group. Risk factors for visual field progression in the low-pressure glaucoma treatment study. Am J Ophthalmol. 2012 Oct;154(4):702-11. doi: 10.1016/j.ajo.2012.04.015. Epub 2012 Jul 25.
PMID: 22835512DERIVEDKrupin T, Liebmann JM, Greenfield DS, Ritch R, Gardiner S; Low-Pressure Glaucoma Study Group. A randomized trial of brimonidine versus timolol in preserving visual function: results from the Low-Pressure Glaucoma Treatment Study. Am J Ophthalmol. 2011 Apr;151(4):671-81. doi: 10.1016/j.ajo.2010.09.026. Epub 2011 Jan 22.
PMID: 21257146DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Theodore Krupin, M.D.
Northwestern University Feinberg School of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 23, 2006
First Posted
April 25, 2006
Study Start
December 1, 1998
Study Completion
May 1, 2004
Last Updated
April 25, 2006
Record last verified: 2006-04