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A Study to Evaluate the Performance and Safety of Artelac Rebalance® Versus Vismed in the Management of Dry Eye

NCT01791426 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2013-10-11

No results posted yet for this study

Summary

The objective of this investigation is to show that the performance of Artelac Rebalance eye drops is non-inferior to that of Vismed eye drops in subjects with moderate to severe dry eye, and to assess the safety of Artelac Rebalance after a 90-day (± 10 day) treatment administered 3 to 5 times per day.

Conditions

  • Dry Eye

Interventions

DEVICE

Artelac Rebalance

Instill 1 drop of the Artelac Rebalance eye drops in each eye 3 to 5 times per day for 90(± 10) day treatment.

DEVICE

Vismed

Instill 1 drop of the Vismed eye drops in each eye 3 to 5 times per day for 90(± 10) day treatment.

Sponsors & Collaborators

  • Bausch & Lomb Incorporated

    lead INDUSTRY

Principal Investigators

  • Helmut Allmeier, PhD · Bausch & Lomb Incorporated

Study Design

Allocation
RANDOMIZED
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2013-10-31
Completion
2013-10-31

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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 NCT01791426 on ClinicalTrials.gov