Table 3.
Treatment group | AEs listed by patient | Incidence, n (%)
|
|||
---|---|---|---|---|---|
Any AE | Ocular AE | Treatment-related AEa | Treatment-related ocular AE | ||
Bimatoprost 0.01% n=67 | Anxiety | 9 (13.4) | 6 (9.0) | 7 (10.4) | 6 (9.0) |
Superficial punctate keratitis | |||||
Periorbital pigmentation, sinus drainage | |||||
Stinging | |||||
Eye burning, eye pain, foreign body sensation, dizzy | |||||
Hyperemia, decreased mental clarity | |||||
Ocular irritation | |||||
Cardiac ischemiab | |||||
Exacerbation of depressionb | |||||
Bimatoprost 0.03% n=62 | Left-sided temporal headache, light flashes OU during periods of darkness | 8 (12.9) | 7 (11.3) | 2 (3.2) | 2 (3.2) |
Allergic conjunctivitis | |||||
Redness | |||||
Subconjunctival hemorrhage | |||||
Branch retinal vein occlusion | |||||
Itching eyelid OU | |||||
Bronchitis | |||||
Uncontrolled IOP |
Notes:
Determined by the investigator to have a possible, probable, or definite relationship to study treatment
serious AE (unrelated to treatment).
Abbreviations: AE, adverse event; IOP, intraocular pressure; OU, both eyes.