CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 460 enrolled
Drug / intervention
Carboxymethylcellulose Based Eye Drop Formulation A +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/NCT01664949
NCT01664949Phase 3Completed
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A Study to Compare the Safety and Efficacy of A New Eye Drop Formulation With OPTIVE™ in Subjects With Dry Eye Disease

Allergan·interventional·Posted Aug 14, 2012·Updated Sep 21, 2015

In Brief

A Phase 3 clinical trial evaluating Carboxymethylcellulose Based Eye Drop Formulation A and Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops for Dry Eye Disease. Completed, enrolled 460 participants across 12 sites in 8 countries.

Detailed Summary

This study will evaluate the safety and efficacy of a carboxymethylcellulose based eye drop formulation compared with carboxymethylcellulose based preservative-free lubricant eye drops (OPTIVE™) in subjects with dry eye disease.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDry Eye Disease
CountriesAustralia, Belgium, France, Germany, Italy, Russia, Spain, United Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 14, 2012
Enrollment StartJan 1, 2013
Primary CompletionMay 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 13.9 years ago

Interventions

Carboxymethylcellulose Based Eye Drop Formulation Adrug

Carboxymethylcellulose Based Eye Drop Formulation A 1-2 drops in each eye as needed at least 2 times daily for 90 days.

Carboxymethylcellulose Based Preservative-Free Lubricant Eye Dropsdrug

Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (OPTIVE™) 1-2 drops in each eye as needed at least 2 times daily for 90 days.