In the previous long-term clinical studies of 1108 patients treated with Trusopt ophthalmic solution alone or as adjunctive therapy with ophthalmic β-blockers, the most frequently reported drug-related adverse effects and local symptoms were: Bitter taste, burning and stinging, blurred vision, eye itching, tearing, headache, conjunctivitis, eyelid inflammation, nausea, eyelid irritation and asthenia/fatigue. The most frequent cause of discontinuation (approximately 3%) from treatment with Trusopt was drug-related ocular adverse effects, primarily conjunctivitis and lid reactions. Iridocyclitis and rash were each reported rarely. There was 1 report of urolithiasis.
In a double-blind, active-treatment controlled, multiple dose, 2-period crossover, randomized multiclinic study, the safety profile of preservative-free Trusopt was similar to that of Trusopt ophthalmic solution.
The following adverse reactions have been reported in post-marketing experience:
Hypersensitivity: Signs and symptoms of local reactions including palpebral reactions and systemic allergic reactions including angioedema, bronchospasm, urticaria and pruritus.
Nervous System: Dizziness, paresthesia.
Ocular: Pain, redness, superficial punctate keratitis, transient myopia (which resolved upon discontinuation of therapy), eyelid crusting, choroidal detachment following filtration surgery.
Skin/Mucous Membranes: Contact dermatitis, throat irritation, dry mouth.
Laboratory Findings: Trusopt was not associated with clinically meaningful electrolyte disturbances.