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A Two Comparator, Controlled Phase 3 Study in Patients With and Without Evaporative Dry Eye

NCT02871440 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-05-12

Study results available
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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

Conditions

  • Dry Eye Syndromes

Interventions

DRUG

Omega 3

DRUG

Optive Advanced

DRUG

Optive

Sponsors & Collaborators

  • Allergan

    collaborator INDUSTRY

  • The University of New South Wales

    lead OTHER

Principal Investigators

  • Fiona Stapleton, PhD · University of New South Wales

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-19
Primary Completion
2017-09-18
Completion
2017-09-18

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02871440 on ClinicalTrials.gov