Efficacy and Safety of PRO-118 Ophthalmic Solution in Allergic Conjunctivitis

• Status: Withdrawn
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Laboratorios Sophia S.A de C.V.
• Treatments: Ophthalmic Solutions; Pharmaceutical Solutions

Criteria

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.