Completed PHASE3 INTERVENTIONAL 2-arm 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

Sponsor: Laboratorios Sophia S.A de C.V.

Conditions Dry Eye

Interventions PRO-148 Systane

Updated 7 times since 2017 Last updated: May 8, 2017 Started: Nov 30, 2013 Primary completion: Feb 28, 2015 Completion: Apr 30, 2015

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT01657253, this PHASE3 trial focuses on Dry Eye and remains completed. Sponsored by Laboratorios Sophia S.A de C.V., it has been updated 7 times since 2013, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

Change History

7 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Dec 2021 — Jul 2024 [monthly]

Completed PHASE3
Jan 2021 — Dec 2021 [monthly]

Completed PHASE3
Jun 2018 — Jan 2021 [monthly]

Completed PHASE3

▶ Show 2 earlier versions

Dec 2017 — Jun 2018 [monthly]

Completed PHASE3

Status: Unknown Status → Completed
Jan 2017 — Dec 2017 [monthly]

Unknown Status PHASE3

First recorded

Nov 2013

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Laboratorios Sophia S.A de C.V.

Data source: Laboratorios Sophia S.A de C.V.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Guadalajara, Mexico