STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PRO-118 OPHTHALMIC SOLUTION IN ALLERGIC CONJUNCTIVITIS

Laboratorios Sophia S.A de C.V.2 sites in 1 countryMarch 2011

ConditionsOcular Itching Ocular Allergy Seasonal Allergic Conjunctivitis Perennial Allergic Conjunctivitis Conjunctivitis, Allergic

InterventionsPRO-118 Ophthalmic Solution 0.020 %PRO-118 Ophthalmic Solution 0.015%PRO-118 Ophthalmic Solution 0.015 %Placebo Ophthalmic Solution

DrugsPRO-118 Ophthalmic Solution 0.015%PRO-118 Ophthalmic Solution 0.015 %PRO-118 Ophthalmic Solution 0.020 %Placebo Ophthalmic Solution

Overview

Phase: Phase 2
Intervention: PRO-118 Ophthalmic Solution 0.020 %
Conditions: Ocular Itching
Sponsor: Laboratorios Sophia S.A de C.V.
Locations: 2
Primary Endpoint: Efficacy of PRO-118 ophthalmic solution.
Status: Withdrawn
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2011

End Date

February 2012

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Laboratorios Sophia S.A de C.V.

Responsible Party

Sponsor

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.

Arms & Interventions

Arm C. PRO-118/Placebo 0.015%,0.020%

Intervention: PRO-118 Ophthalmic Solution 0.020 %

Arm D. PRO-118/Placebo 0.015%,0.020%

Intervention: PRO-118 Ophthalmic Solution 0.020 %

Arm A. PRO-118/Placebo 0.015%,0.020%

Intervention: PRO-118 Ophthalmic Solution 0.015%

Arm B. PRO-118/Placebo 0.015%,0.020%

Intervention: PRO-118 Ophthalmic Solution 0.015 %

Arm E PRO-118/Placebo 0.015%,0.020%

Intervention: Placebo Ophthalmic Solution

Outcomes

Primary Outcomes

Efficacy of PRO-118 ophthalmic solution.

Time Frame: 21 days.

Primary efficacy measure: Evaluation of ocular itching. Secondary efficacy measures: Evaluation of symptoms(redness eye,ocular irritation, foreign body sensation, photophobia and lacrimation) and signs(conjunctival hyperaemia,chemosis, mucous discharge ocular and presence of follicles/papillae).