At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 40 enrolled
Drug / intervention
Omega 3 +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.
A Two Comparator, Controlled Phase 3 Study of OM3 Tear Formulation Versus OPTIVE ADVANCED Unit Dose and OPTIVE Unit Dose Eye Drops in Patients With and Without Evaporative Dry Eye.
In Brief
A Phase 3 clinical trial evaluating Omega 3, Optive Advanced, and 1 other intervention for Dry Eye Syndromes. Completed, enrolled 40 participants.
Detailed Summary
Omega 3 (OM3) Tear is a new unit dose emulsion, containing flaxseed/castor oil, which is being developed by Allergan. It is desirable to understand the effect that this new emulsion has on tear film evaporation and tear lipid profile via interferometry, in patients with evaporative dry eye (EDE) and those without (non-EDE). It would also be valuable to evaluate the retention time of the lipid components of the new emulsion via tear collection and analysis in EDE and non-EDE patients
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDry Eye Syndromes
Countries--
CollaboratorsAllergan
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedAug 2016
Enrollment StartSep 2016
Primary CompletionSep 2017
TodayJul 2026
First PostedAug 18, 2016
Enrollment StartSep 19, 2016
Primary CompletionSep 18, 2017
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 9.9 years ago
Interventions
Omega 3drug
Optive Advanceddrug
Optivedrug