Clinical Studies Experience
Because clinical studies are conducted under widely
varying conditions, adverse reaction rates observed in the clinical studies of
a drug cannot be directly compared to rates in the clinical studies of another
drug and may not reflect the rates observed in practice.
In clinical studies, the most common ocular adverse
reactions with use of Rescula were burning/stinging, burning/stinging upon drug
instillation, dry eyes, itching, increased length of eyelashes, and injection.
These were reported in approximately 10–25% of patients. Approximately 10–14%
of patients were observed to have an increase in the length of eyelashes
( ≥ 1 mm) at 12 months, while 7% of patients were observed to have a
decrease in the length of eyelashes.
Ocular adverse reactions occurring in approximately 5–10%
of patients were abnormal vision, eyelid disorder, foreign body sensation, and
Ocular adverse reactions occurring in approximately 1–5%
of patients were blepharitis, cataract, conjunctivitis, corneal lesion,
discharge from the eye, eye hemorrhage, eye pain, keratitis, irritation,
photophobia, and vitreous disorder.
Other ocular adverse reactions reported in less than 1%
of patients were acute elevated intraocular pressure, color blindness, corneal
deposits, corneal edema, corneal opacity, diplopia, hyperpigmentation of the
eyelid, increased number of eyelashes, iris hyperpigmentation, iritis, optic
atrophy, ptosis, retinal hemorrhage, and visual field defect.
The most frequently reported nonocular adverse reaction
associated with the use of Rescula in the clinical trials was flu-like syndrome
that was observed in approximately 6% of patients. Nonocular adverse reactions
reported in the 1–5% of patients were accidental injury, allergic reaction,
back pain, bronchitis, increased cough, diabetes mellitus, dizziness, headache,
hypertension, insomnia, pharyngitis, pain, rhinitis, and sinusitis.
The following adverse reactions have been identified
during post-approval use of Rescula. Because these reactions are reported
voluntarily from a population of uncertain size, it is not always possible to
reliably estimate their frequency or establish a causal relationship to drug
Voluntary reports of adverse reactions occurring with the
use of Rescula include corneal erosion.
There have been rare spontaneous reports with a different
formulation of unoprostone isopropyl (0.12%) of chemosis, dry mouth, nausea,
vomiting and palpitations.
No information provided.