Travoprost 0.004% with and without benzalkonium chloride: a comparison of safety and efficacy.
OBJECTIVE
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.


CONCLUSIONS
Travoprost 0.004% without BAC is equivalent to travoprost 0.004% with BAC in both safety and efficacy.
Lewis
Richard A
RA
Grutzmacher and Lewis, Inc, Sacramento, CA, USA.
Katz
Gregory J
GJ
Weiss
Mark J
MJ
Landry
Theresa A
TA
Dickerson
Jaime E
JE
James
John E
JE
Hua
Steven Y
SY
Sullivan
E Kenneth
EK
Montgomery
Dawnelle B
DB
Wells
David T
DT
Bergamini
Michael V W
MV
D000368:Aged; D000959:Antihypertensive Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D001548:Benzalkonium Compounds / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D002626:Chemistry, Pharmaceutical; D003008:Cloprostenol / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D004311:Double-Blind Method; D005260:Female; D005902:Glaucoma, Open-Angle / Q000188:drug therapy*; D006068:Gonioscopy; D006801:Humans; D007429:Intraocular Pressure / Q000187:drug effects*; D008297:Male; D008875:Middle Aged; D009798:Ocular Hypertension / Q000188:drug therapy; D009883:Ophthalmic Solutions / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D011310:Preservatives, Pharmaceutical / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D014065:Tonometry, Ocular; D000069557:Travoprost; D016896:Treatment Outcome
D000959:Antihypertensive Agents; D001548:Benzalkonium Compounds; D009883:Ophthalmic Solutions; D011310:Preservatives, Pharmaceutical; D003008:Cloprostenol; D000069557:Travoprost