Document Detail

Travoprost 0.004% with and without benzalkonium chloride: a comparison of safety and efficacy.
MedLine Citation:
PMID:  17224758     Owner:  NLM     Status:  MEDLINE    
PURPOSE: To compare the safety and efficacy of travoprost 0.004% without benzalkonium chloride (BAC) to that of the marketed formulation of travoprost 0.004% in patients with open-angle glaucoma or ocular hypertension. 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.
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;
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Publication Detail:
Type:  Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Journal of glaucoma     Volume:  16     ISSN:  1057-0829     ISO Abbreviation:  J. Glaucoma     Publication Date:  2007 Jan 
Date Detail:
Created Date:  2007-01-16     Completed Date:  2007-03-05     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9300903     Medline TA:  J Glaucoma     Country:  United States    
Other Details:
Languages:  eng     Pagination:  98-103     Citation Subset:  IM    
Grutzmacher and Lewis, Inc, Sacramento, CA, USA.
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MeSH Terms
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
Glaucoma, Open-Angle / drug therapy*
Intraocular Pressure / drug effects*
Middle Aged
Ocular Hypertension / drug therapy
Ophthalmic Solutions / administration & dosage,  adverse effects,  therapeutic use
Preservatives, Pharmaceutical / administration & dosage*,  adverse effects,  therapeutic use
Tonometry, Ocular
Treatment Outcome
Reg. No./Substance:
0/Antihypertensive Agents; 0/Benzalkonium Compounds; 0/Ophthalmic Solutions; 0/Preservatives, Pharmaceutical; 157283-68-6/travoprost; 40665-92-7/Cloprostenol

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