Allergic Conjunctivitis Clinical Trial
Official title:
Phase 3 Clinical Trial to Evaluate the Clinical Efficacy of PRO-118 Compared With Olopatadine Hydrochloride Ophthalmic Solution in Allergic Conjunctivitis
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.
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