At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 183 enrolled
Drug / intervention
PRO-148 +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.
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
In Brief
A Phase 3 clinical trial evaluating PRO-148 and Systane for Dry Eye. Completed, enrolled 183 participants across 1 site.
Detailed 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®
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDry Eye
CountriesMexico
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 2012
Enrollment StartNov 2013
Primary CompletionFeb 2015
Study CompletionApr 2015
TodayJul 2026
First PostedAug 6, 2012
Enrollment StartNov 1, 2013
Primary CompletionFeb 1, 2015
Study CompletionApr 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 13.9 years ago
Interventions
PRO-148drug
Instill 1 drop in each eye four times a day, for 60 days
Systanedrug
Instill 1 drop in each eye four times a day, for 60 days