Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2025-12-24 @ 9:21 PM
NCT ID:
NCT01541904
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Study:
NCT01541904
Study Brief:
Protocol Section:
NCT01541904