CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 315 enrolled
Drug / intervention
Carboxymethylcellulose Based Eye Drop Formulation A +3 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/NCT01459588
NCT01459588Phase 3Completed
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Safety, Efficacy, and Acceptability Study of an Eye Drop Formulation in Subjects With Dry Eye Disease

Allergan·interventional·Posted Oct 25, 2011·Updated Apr 16, 2019

In Brief

A Phase 3 clinical trial evaluating Carboxymethylcellulose Based Eye Drop Formulation A, Carboxymethylcellulose Based Eye Drop Formulation B, and 2 other interventions for Dry Eye Syndromes. Completed, enrolled 315 participants across 1 site.

Detailed Summary

This study will evaluate the safety, efficacy, and acceptability of an eye drop formulation in subjects with dry eye disease.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDry Eye Syndromes
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 25, 2011
Enrollment StartOct 1, 2011
Primary CompletionFeb 15, 2012
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 14.7 years ago

Interventions

Carboxymethylcellulose Based Eye Drop Formulation Adrug

Carboxymethylcellulose Based Eye Drop Formulation A (Refresh Optive® Advanced Sensitive Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.

Carboxymethylcellulose Based Eye Drop Formulation Bdrug

Carboxymethylcellulose Based Eye Drop Formulation B (Refresh Optive® Advanced Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.

Carboxymethylcellulose Based Preservative-Free Lubricant Eye Dropsdrug

Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Optive® Sensitive Preservative-Free Lubricant Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.

Carboxymethylcellulose Based Lubricant Eye Dropsdrug

Carboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.