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

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.

Conditions

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

Interventions

DRUG

PRO-118 Ophthalmic Solution 0.015%

PRO-118 Ophthalmic Solution 0.015 % applied qd during 21 days

DRUG

PRO-118 Ophthalmic Solution 0.015 %

PRO-118 Ophthalmic Solution 0.015 % applied twice to day during 21 days

DRUG

PRO-118 Ophthalmic Solution 0.020 %

PRO-118 Ophthalmic Solution 0.020 % applied qd during 21 days

DRUG

PRO-118 Ophthalmic Solution 0.020 %

PRO-118 Ophthalmic Solution 0.020 % applied twice to day during 21 days

DRUG

Placebo Ophthalmic Solution

Placebo Ophthalmic Solution applied qd during 21 days

Sponsors & Collaborators

• Laboratorios Sophia S.A de C.V.

  lead INDUSTRY

Principal Investigators

• María C Jiménez-Martínez, MD · "Instituto de Oftalmología Fundación Conde de Valenciana, I.A.P."

• Concepción Santacruz-Valdés, MD · "Instituto de Oftalmología Fundación Conde de Valenciana, I.A.P."

• Emma T Villaseñor-Fierro, MD · Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"

• Miriam Becerra-Cotta, MD · Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"

• Leopoldo M Baiza-Durán, MD · Clinical Research Department. Laboratorios Sophia SA de CV

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

6 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-03-31

Primary Completion

2012-02-29

Completion

2012-02-29

Countries

• Mexico

Study Locations