Efficacy and Safety of PRO-118 Ophthalmic Solution in Allergic Conjunctivitis
STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PRO-118 OPHTHALMIC SOLUTION IN ALLERGIC CONJUNCTIVITIS
Lead SponsorLaboratorios Sophia S.A de C.V.
The purpose of this study is to evaluate the efficacy and safety of four doses of PRO-118 ophthalmic solution ophthalmic solution compared with placebo, for the treatment of seasonal (SAC) and perennial (PAC) allergic conjunctivitis.
A phase II, double-masked, randomized, placebo-controlled, parallel-group and multicenter clinical trial, to evaluate and compared the clinical efficacy and safety of four doses of PRO-118 ophthalmic solution ( PRO-118 0.015% qd, PRO-118 0.015% twice daily , PRO-118 0.020% qd, PRO-118 0.020% twice daily) for the treatment of seasonal (SAC) and perennial (PAC) allergic conjunctivitis.
PRO-118 Ophthalmic Solution 0.015 % applied qd during 21 days
PRO-118 Ophthalmic Solution 0.015 % applied twice to day during 21 days
PRO-118 Ophthalmic Solution 0.020 % applied qd during 21 days
PRO-118 Ophthalmic Solution 0.020 % applied twice to day during 21 days
Placebo Ophthalmic Solution applied qd during 21 days
Inclusion Criteria: Patients with diagnosis of seasonal or perennial allergic conjunctivitis. Age ≥ 6 years old at screening visit. Male or female patients. Applicable in patients ≥ 18 years old. Patient has signed the Informed Consent Form (ICF) prior to any screening procedures. Applicable in patients with age ≤ 18 years old. Patients Patients'parents or legal guardians signed an Informed Consent Form (ICF). The patients also provided written assent. Exclusion Criteria: Presence of any form of allergic conjunctivitis other than seasonal or perennial allergic conjunctivitis (Atopic keratoconjunctivitis, giant papillary conjunctivitis). Any other ophthalmic medication within seven days prior to randomization. Patient with one blind eye. Visual acuity of 20/40 in any eye. Patients with history of active stage of any other concomitant ocular disease. Contraindications or sensitivity to any component of the study treatments. Contact lens users. Ocular surgery within the past 3 months. Women who were not using an effective means of contraception or who were pregnant or nursing. Participation in any studies of investigational drugs within 90 days previous to the inclusion. Discontinuation criteria: Patients could be discontinued before the completion of the study because of use of prohibited medications, adverse events, pregnancy, protocol violations, lack of efficacy, or administrative reasons.