NCT01657253

Efficacy and Safety of PRO-148 Versus Systane®, in Patients With Mild to Moderate Dry Eye

A Randomized, Double-blind, Phase III Clinical Trial to Evaluate the Efficacy and Safety of PRO-148 Versus Systane®, in Patients With Mild to Moderate Dry Eye

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 183 (actual)
• Sponsor: Laboratorios Sophia S.A de C.V. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate efficacy and safety of the ophthalmic solution PRO-148 in the ocular surface of patients with mild to moderate dry eye compared with ophthalmic solution Systane®

Detailed description

Dry eye is a multifactorial disease of the tears and ocular surface that results in symptoms of discomfort, visual disturbance, and tear film instability with potential damage to the ocular surface. Current treatment is heavily weighted toward supplementation, stimulation, or preservation of aqueous tears. Artificial tears are one of the primary treatments for dry eye; it is mainly palliative and focuses on reducing the symptoms of discomfort to improve quality of life for a patient. A phase III randomized double-blind clinical trial will be conducted to evaluate efficacy and safety of the ophthalmic solution PRO-148 in the ocular surface of patients with mild to moderate dry eye compared with ophthalmic solution Systane®. Patients will be randomized to receive one of the treatments for 60 days. Efficacy and safety measures will be performed at baseline and at 60 days after treatment

Conditions

• Dry Eye

Interventions

Type	Name	Description
DRUG	PRO-148	Instill 1 drop in each eye four times a day, for 60 days
DRUG	Systane	Instill 1 drop in each eye four times a day, for 60 days

Timeline

• Start date: 2013-11-01
• Primary completion: 2015-02-01
• Completion: 2015-04-01
• First posted: 2012-08-06
• Last updated: 2017-12-15
• Results posted: 2017-12-15

Locations

1 site across 1 country: Mexico