Abstract | PURPOSE: DESIGN: Randomized, double-masked, parallel group, multicenter equivalence study. PARTICIPANTS: Eight hundred forty-two patients randomized to the study treatments. METHODS: Patients with OAG or OHT and with qualifying IOP (22-36 mmHg at 8 am on 2 eligibility visits after an appropriate washout period from previous treatment) were assigned randomly to either brimonidine tartrate 0.15% preserved with polyquaternium-1 ( brimonidine PQ) or brimonidine tartrate 0.15% preserved with chlorine dioxide ( brimonidine P) dosed 3 times daily and were followed up for 6 months. Approximately one half of the study sites continued to follow up their patients for an additional 6 months to obtain longer-term safety data. RESULTS:
Brimonidine PQ produced statistically significant and clinically relevant reductions from baseline ranging from 4.3 to 6.5 mmHg, which were statistically and clinically equivalent to brimonidine P at all 18 visit days and times. No safety concerns were identified based on an assessment of ocular and cardiovascular parameters. Patient discontinuations resulting from adverse events were similar for both groups and most of these were a result of signs or symptoms of ocular allergic reaction. CONCLUSIONS:
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Authors | Jess T Whitson, Katherine I Ochsner, Marlene R Moster, E Kenneth Sullivan, Russell M Andrew, Lewis H Silver, David T Wells, John E James, Charles F Bosworth, Jaime E Dickerson, Theresa A Landry, Michael V W Bergamini, Brimonidine 0.15% Study Group |
Journal | Ophthalmology
(Ophthalmology)
Vol. 113
Issue 8
Pg. 1333-9
(Aug 2006)
ISSN: 1549-4713 [Electronic] United States |
PMID | 16877072
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Adrenergic alpha-Agonists
- Chlorine Compounds
- Drug Combinations
- Oxides
- Polymers
- Preservatives, Pharmaceutical
- Quinoxalines
- Brimonidine Tartrate
- polyquaternium 1
- chlorine dioxide
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Topics |
- Adrenergic alpha-Agonists
(adverse effects, pharmacokinetics, therapeutic use)
- Aged
- Brimonidine Tartrate
- Chlorine Compounds
(adverse effects, pharmacokinetics)
- Double-Blind Method
- Drug Combinations
- Female
- Glaucoma, Open-Angle
(drug therapy, physiopathology)
- Humans
- Intraocular Pressure
(drug effects)
- Male
- Middle Aged
- Ocular Hypertension
(drug therapy, physiopathology)
- Oxides
(adverse effects, pharmacokinetics)
- Polymers
(adverse effects, pharmacokinetics)
- Preservatives, Pharmaceutical
(adverse effects, pharmacokinetics)
- Quinoxalines
(adverse effects, pharmacokinetics, therapeutic use)
- Therapeutic Equivalency
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