Abstract
Purpose::
to evaluate the relative comfort and hyperemia associated with instillation of travoprost 0.004% with and without BAK in subjects naive to topical glaucoma therapy.
Methods::
In this double-masked randomized prospective study, 18 subjects (6 male, 12 female) with median age of 30 (age range of 25-54) and no prior history of glaucoma medication use were randomly assigned to receive either a drop of travoprost 0.004% with BAK or without BAK in the right eye. The left eye then received the alternate medication. Subjects were evaluated 9 hours post-instillation of drops. Photographs of each pair of eyes were taken and subjects were asked to grade their discomfort on a scale of 0-4 (zero corresponding to no discomfort and 4 corresponding to extreme discomfort). The relative degree of bulbar conjunctival hyperemia was assessed by 4 masked observers evaluating the photographs.
Results::
Moderate to severe discomfort was reported by 6 subjects after instillation of travoprost with BAK, compared with 5 subjects after instillation of travoprost without BAK. Five of the 6 subjects who had reported moderate to severe discomfort, noted less discomfort in the eye that had received travoprost without BAK. Moderate to severe discomfort was reported in all ten subjects with moderate to severe hyperemia. More severe hyperemia was associated with instillation of travoprost with BAK in 9 out of 10 subjects. All subjects with a history of contact lens wear and/or dry eyes reported at least moderate discomfort and hyperemia in at least one eye.
Conclusions::
Travoprost without BAK appears to cause less discomfort and hyperemia than travorprost with BAK in subjects with high risk characteristics, such as dry eye syndrome and contact lens wear, who tend to experience more severe ocular side effects from eye drops.
Keywords: drug toxicity/drug effects • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • ocular irritants