At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 242 enrolled
Drug / intervention
Carboxymethylcellulose Based Eye Drop +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 Multicenter, Double-masked, Randomized Study to Compare the Safety and Efficacy of the OM3 Tear Formulation With REFRESH OPTIVE® ADVANCED Unit Dose for 3 Months in Patients With Dry Eye Disease
In Brief
A Phase 3 clinical trial evaluating Carboxymethylcellulose Based Eye Drop and Carboxymethylcellulose Sodium 0.5% for Dry Eye Syndromes. Completed, enrolled 242 participants across 13 sites in 2 countries.
Detailed Summary
This study will evaluate the safety and efficacy of a new eye drop formulation in patients with dry eye disease.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDry Eye Syndromes
CountriesAustralia, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 2015
Enrollment StartJan 2016
Primary CompletionSep 2016
TodayJul 2026
First PostedSep 18, 2015
Enrollment StartJan 6, 2016
Primary CompletionSep 9, 2016
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 10.8 years ago
Interventions
Carboxymethylcellulose Based Eye Dropdrug
Carboxymethylcellulose based eye drop (OM3 Tear) administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.
Carboxymethylcellulose Sodium 0.5%drug
Carboxymethylcellulose sodium 0.5% (REFRESH OPTIVE® ADVANCED) administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.