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

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.

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.