Clinical trial NCT01541904: Efficacy and Safety of PRO-118 Ophthalmic Solution in Allergic Conjunctivitis
Official title: STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PRO-118 OPHTHALMIC SOLUTION IN ALLERGIC CONJUNCTIVITIS
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Ocular Itching
Ocular Allergy
Seasonal Allergic Conjunctivitis
Perennial Allergic Conjunctivitis
Conjunctivitis, Allergic
Keywords: Ocular Allergy.
Seasonal Allergic Conjunctivitis
Perennial Allergic Conjunctivitis
Conjunctivitis, Allergic
Ocular Antihistamines.
Lead sponsor: Laboratorios Sophia S.A de C.V.
Sponsor class: INDUSTRY
First posted: 2012-03-01
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

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.

Primary outcomes:
measure: Efficacy of PRO-118 ophthalmic solution.
timeFrame: 21 days.
Secondary outcomes:
measure: Safety of PRO-118 Ophthalmic Solution.
timeFrame: 21 days.
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"
state: Jalisco
city: Mexico City
country: Mexico
facility: "Instituto de Oftalmología Fundación Conde de Valenciana, I.A.P
Study officials:
affiliation: "Instituto de Oftalmología Fundación Conde de Valenciana, I.A.P."
name: María C Jiménez-Martínez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: "Instituto de Oftalmología Fundación Conde de Valenciana, I.A.P."
name: Concepción Santacruz-Valdés, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"
name: Emma T Villaseñor-Fierro, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"
name: Miriam Becerra-Cotta, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Research Department. Laboratorios Sophia SA de CV
name: Leopoldo M Baiza-Durán, MD
role: STUDY_DIRECTOR
References: