Abstract | PURPOSE: METHODS: The study was a double-masked, randomized, parallel group, multicenter, noninferiority design. Adult patients with open-angle glaucoma or ocular hypertension with qualifying intraocular pressure (IOP) on 2 eligibility visits received either travoprost 0.004% with BAC (n=346), or travoprost 0.004% without BAC (n=344) dosed once-daily each evening. Patients were followed for a period of 3 months. IOP measurements at 8 AM, 10 AM, and 4 PM were taken at study visits on week 2, week 6, and month 3. RESULTS: Mean IOP reductions, across all 9 study visits and times ranged from 7.3 to 8.5 mm Hg for travoprost 0.004% without BAC and from 7.4 to 8.4 mm Hg for travoprost 0.004% with BAC. Statistical equivalence was also demonstrated for the comparison of mean IOP changes; 95% confidence limits were within +/-0.8 mm Hg at 9 of 9 study visits and times in both the per protocol and intent-to-treat data sets. Adverse events and the number of patients discontinued owing to adverse events were similar for both treatment groups. Adverse events due to hyperemia occurred in 6.4% and 9.0% of patients treated with travoprost 0.004% without BAC and travoprost 0.004% with BAC, respectively. CONCLUSION:
Travoprost 0.004% without BAC is equivalent to travoprost 0.004% with BAC in both safety and efficacy.
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Authors | Richard A Lewis, Gregory J Katz, Mark J Weiss, Theresa A Landry, Jaime E Dickerson, John E James, Steven Y Hua, E Kenneth Sullivan, Dawnelle B Montgomery, David T Wells, Michael V W Bergamini, Travoprost BAC-free Study Group |
Journal | Journal of glaucoma
(J Glaucoma)
Vol. 16
Issue 1
Pg. 98-103
(Jan 2007)
ISSN: 1057-0829 [Print] United States |
PMID | 17224758
(Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antihypertensive Agents
- Benzalkonium Compounds
- Ophthalmic Solutions
- Preservatives, Pharmaceutical
- Cloprostenol
- Travoprost
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Topics |
- Aged
- Antihypertensive Agents
(administration & dosage, adverse effects, therapeutic use)
- Benzalkonium Compounds
(administration & dosage, adverse effects, therapeutic use)
- Chemistry, Pharmaceutical
- Cloprostenol
(administration & dosage, adverse effects, analogs & derivatives, therapeutic use)
- Double-Blind Method
- Female
- Glaucoma, Open-Angle
(drug therapy)
- Gonioscopy
- Humans
- Intraocular Pressure
(drug effects)
- Male
- Middle Aged
- Ocular Hypertension
(drug therapy)
- Ophthalmic Solutions
(administration & dosage, adverse effects, therapeutic use)
- Preservatives, Pharmaceutical
(administration & dosage, adverse effects, therapeutic use)
- Tonometry, Ocular
- Travoprost
- Treatment Outcome
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