CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 305 enrolled
Drug / intervention
carboxymethylcellulose sodium based New Eye Drop Formulation 1 +2 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/NCT01294384
NCT01294384Phase 3Completed
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Safety and Efficacy Study of New Eye Drop Formulations With Refresh Tears® in Patients With Dry Eye Disease

Allergan·interventional·Posted Feb 11, 2011·Updated Apr 16, 2019

In Brief

A Phase 3 clinical trial evaluating carboxymethylcellulose sodium based New Eye Drop Formulation 1, carboxymethylcellulose sodium based New Eye Drop Formulation 2, and 1 other intervention for Dry Eye Syndromes. Completed, enrolled 305 participants across 2 sites in 2 countries.

Detailed Summary

This study will investigate the safety, efficacy and acceptability of two new eye drop formulations compared with Refresh Tears® in patients with dry eye disease.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDry Eye Syndromes
CountriesAustralia, Canada
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 11, 2011
Enrollment StartMay 1, 2011
Primary CompletionSep 25, 2012
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 15.4 years ago

Interventions

carboxymethylcellulose sodium based New Eye Drop Formulation 1drug

1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.

carboxymethylcellulose sodium based New Eye Drop Formulation 2drug

1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.

carboxymethylcellulose sodium based Eye Dropsdrug

1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.