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Efficacy and Safety of PRO-118 Ophthalmic Solution in Allergic Conjunctivitis | Clinical Trials | Clareo Health

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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

NCT01541904•Laboratorios Sophia S.A de C.V.

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

Age

6 - No limit years

Sex

ALL

Healthy Volunteers

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.
+2 more criteria

Locations (2)

Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"

Guadalajara, Jalisco, Mexico

"Instituto de Oftalmología Fundación Conde de Valenciana, I.A.P

Mexico City, Mexico

Key Dates

Start Date

March 1, 2011

Primary Completion Date

February 1, 2012

Completion Date

February 1, 2012

Last Updated

October 2, 2018

Conditions

Ocular ItchingOcular AllergySeasonal Allergic ConjunctivitisPerennial Allergic ConjunctivitisConjunctivitis, Allergic

Interventions

PRO-118 Ophthalmic Solution 0.015%

DRUG

PRO-118 Ophthalmic Solution 0.015 %

DRUG

PRO-118 Ophthalmic Solution 0.020 %

DRUG

PRO-118 Ophthalmic Solution 0.020 %

DRUG

Placebo Ophthalmic Solution

DRUG

Ketotifen Ophthalmic Solution With Emedastine in Patients With Seasonal Allergic Conjunctivitis

NCT00133627

Seasonal Allergic Conjunctivitis

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 2, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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