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Clinical Trials/NCT00348517
NCT00348517CompletedNot Applicable

An Evaluation of the Safety and Efficacy of Systane Free FID 105783

Alcon Research0 sites100 target enrollmentStarted: July 2006Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
100
Primary Endpoint
Change in corneal staining at Day 28 from baseline (Day 0)
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The objective of this study is to evaluate the safety and efficacy of Systane Free FID 105783 when compared to Refresh Liquigel Lubricant Eye Drops (Allergan) in a specified population of dry eye patients.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •>/= 3 corneal staining score using NEI scoring system.
  • •Need artificial tears at least some of the time.
  • •Other protocol-defined inclusion criteria may apply.

Exclusion Criteria

  • •History or evidence of ocular or intraocular surgery in either eye within the past six months.
  • •History of intolerance or hypersensitivity to any component of the study medication.
  • •Use of Restasis within 30 days of Visit
  • •Participation in an investigational drug or device study within 30 days of entering this study.
  • •Other protocol-defined exclusion criteria may apply.

Outcomes

Primary Outcomes

Change in corneal staining at Day 28 from baseline (Day 0)

Time Frame: Day 28

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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