Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT01541904

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

Status
Withdrawn
Phase
Phase 2
Study type
Interventional
Enrollment
0 (actual)
Sponsor
Laboratorios Sophia S.A de C.V. · Industry
Sex
All
Age
6 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGPRO-118 Ophthalmic Solution 0.015%PRO-118 Ophthalmic Solution 0.015 % applied qd during 21 days
DRUGPRO-118 Ophthalmic Solution 0.015 %PRO-118 Ophthalmic Solution 0.015 % applied twice to day during 21 days
DRUGPRO-118 Ophthalmic Solution 0.020 %PRO-118 Ophthalmic Solution 0.020 % applied qd during 21 days
DRUGPRO-118 Ophthalmic Solution 0.020 %PRO-118 Ophthalmic Solution 0.020 % applied twice to day during 21 days
DRUGPlacebo Ophthalmic SolutionPlacebo Ophthalmic Solution applied qd during 21 days

Timeline

Start date
2011-03-01
Primary completion
2012-02-01
Completion
2012-02-01
First posted
2012-03-01
Last updated
2018-10-02

Locations

2 sites across 1 country: Mexico

Source: ClinicalTrials.gov record NCT01541904. Inclusion in this directory is not an endorsement.