The purpose of this study is to evaluate the clinical efficacy of the ophthalmic solution PRO-118 compared with olopatadine hydrochloride ophthalmic solution in allergic conjunctivitis.
Allergic conjunctivitis is inflammation of the tissue lining the eyelids (conjunctiva) due to a reaction from allergy-causing substances. The main aim in allergic conjunctivitis is to improve the quality of life in these patients. Antihistaminic medication is commonly used to treat allergic conjunctivitis symptoms. The aim of the study is to compare the clinical efficacy of two ophthalmic solutions containing each one an antihistaminic drug. A phase III randomized double-blind clinical trial will be conducted to evaluate efficacy of the ophthalmic solution PRO-118 compared with olopatadine hydrochloride ophthalmic solution in allergic conjunctivitis. Patients will be randomized to receive one of the treatments for 21 days. Efficacy endpoints will be measured at baseline and at 21 days after treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
instill one drop in each eye once a day for 21 days
instill one drop in each eye once a day for 21 days
conjunctival hyperemia
Change from Baseline in conjunctival hyperemia after 21 days of treatment
Time frame: day 21
epiphora
Change from Baseline in epiphora after 21 days of treatment
Time frame: day 21
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