CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
PRO-148 Ophthalmic Solution +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01541891
NCT01541891Phase 2Completed
CompareCT.gov

Fase II Comparative Study of the Efficacy and Safety of PRO-148 Ophthalmic Solution vs Systane in the Treatment of Mild-to-moderate Eye Syndrome.

Laboratorios Sophia S.A de C.V.·interventional·Posted Mar 1, 2012·Updated Oct 30, 2018

In Brief

A Phase 2 clinical trial evaluating PRO-148 Ophthalmic Solution and Active Comparator: SYSTANE ® Ophthalmic Solution for Dry Eye Syndrome. Completed, enrolled 30 participants across 1 site.

Detailed Summary

The purpose of this study is to evaluate the efficacy and safety of PRO-148 ophthalmic solution compared with SYSTANE ® ophthalmic solution for the treatment of signs and symptoms of mild-to-moderate dry eye syndrome.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDry Eye Syndrome
CountriesMexico
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 1, 2012
Enrollment StartOct 1, 2011
Primary CompletionMar 1, 2012
Study CompletionMay 1, 2012
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 14.3 years ago

Interventions

PRO-148 Ophthalmic Solutiondrug

PRO-148 Ophthalmic Solution applied four times per day (c/6 hours) during 60 days.

Active Comparator: SYSTANE ® Ophthalmic Solutiondrug

Sterile solution containing polyethylene glycol 400, propylene glycol, hydroxypropyl-guar, boric acid, calcium chloride, magnesium chloride, potassium chloride, sodium chloride, zinc chloride and polyquad (polidronium chloride) 0,001%. four times per day (c/6 hours) during 60 days.