Abstract | PURPOSE: METHODS: A total of 371 patients randomly received travoprost BAK-free (n=185) or travoprost BAK (n=186) dosed once daily in the evening for 3 months. Patients were evaluated at 9 am, 11 AM, and 4 PM at baseline, weeks 2 and 6, and month 3. Intraocular pressure was also evaluated 36 and 60 hours after the month 3 visit. RESULTS:
Travoprost BAK-free is non-inferior to travoprost BAK. The 95% upper confidence limits for the difference in mean IOP at month 3 (primary efficacy) were 0.5 mmHg, 0.6 mmHg, and 0.5 mmHg, at 9 AM, 11 AM, and 4 PM, respectively. Mean IOP reductions from baseline ranged from 7.6 to 8.7 mmHg in the travoprost BAK-free group and from 7.7 to 9.2 mmHg in the travoprost BAK group. At 36 and 60 hours after the last dose, mean IOP remained 6.8 mmHg and 5.7 mmHg below baseline in the travoprost BAK-free group, vs 7.3 mmHg and 6.0 mmHg in the travoprost BAK group, respectively. The safety profile of travoprost BAK-free was similar to that of travoprost BAK. CONCLUSIONS:
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Authors | Stefano Gandolfi, Tania Paredes, Ivan Goldberg, Michael Coote, Anthony Wells, Lasma Volksone, Manju R Pillai, Ingeborg Stalmans, Philippe Denis, Travoprost Bak-Free Clinical Study Group |
Journal | European journal of ophthalmology
(Eur J Ophthalmol)
2012 Jan-Feb
Vol. 22
Issue 1
Pg. 34-44
ISSN: 1724-6016 [Electronic] United States |
PMID | 22167541
(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
- Polymers
- Preservatives, Pharmaceutical
- Cloprostenol
- polyquaternium 1
- Travoprost
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Topics |
- Aged
- Antihypertensive Agents
(administration & dosage, adverse effects)
- Benzalkonium Compounds
(administration & dosage, adverse effects)
- Cloprostenol
(administration & dosage, adverse effects, analogs & derivatives)
- Double-Blind Method
- Female
- Glaucoma, Open-Angle
(drug therapy, physiopathology)
- Humans
- Intraocular Pressure
(drug effects)
- Male
- Middle Aged
- Ocular Hypertension
(drug therapy, physiopathology)
- Polymers
(administration & dosage, adverse effects)
- Preservatives, Pharmaceutical
(administration & dosage, adverse effects)
- Prospective Studies
- Tonometry, Ocular
- Travoprost
- Treatment Outcome
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