Product Preference With Systane Compared to Artificial Tears on Frequency of Drop Use

NCT ID: NCT00347984

Last Updated: 2012-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-12-31
• Study Completion Date: 2006-02-28

Brief Summary

The objective of this study was to evaluate the effect of Systane® compared to marketed artificial tears on the frequency of drop use.

Conditions

Dry Eye

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Systane Lubricant eye drops

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Subjects age 18 (minimum); reported history of dry eye syndrome in both eyes; TFBUT ≤ 7 seconds in at least 1 eye at Visit 1; ≥ 1+ fluorescein staining score in any region in at least 1 eye at Visit 1; desire to use an artificial tear substitute for dry eye symptoms at least 4 times per day at Visit 1 and Visit 2.

Exclusion Criteria

• Age less than 18 years

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ORA, Inc.

INDUSTRY

Sponsor Role: collaborator

Alcon Research

INDUSTRY

Sponsor Role: lead

Principal Investigators

Mike Christensen

Role: STUDY_DIRECTOR

Alcon Research

Locations

Maryland

Andover, Massachusetts, United States

Countries

United States

Other Identifiers

05-004-09

Identifier Type: -

Identifier Source: org_study_id