This study will evaluate the long-term safety of bimatoprost 0.01% ophthalmic solution compared with bimatoprost 0.03% ophthalmic solution in patients with glaucoma or ocular hypertension.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
806
One drop of bimatoprost 0.01% ophthalmic solution instilled to each eye, once daily in the evening for 2 years.
One drop of bimatoprost 0.03% ophthalmic solution instilled to each eye, once daily in the evening for 2 years.
Percentage of Participants Reporting One or More Treatment-Related Ocular Surface Adverse Events
An adverse event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. The percentage of participants with ocular (eye) surface AEs deemed related to treatment by the investigator are reported.
Time frame: 24 Months
Percentage of Participants Reporting One or More Treatment-Related Ocular Surface Adverse Events Excluding "Conjunctival Hyperemia"
An adverse event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. The percentage of participants with ocular (eye) surface AEs deemed related to treatment by the investigator excluding AEs with the preferred term Conjunctival hyperemia are reported.
Time frame: 24 Months
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