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NCT00607776 Clinical Trial

Artificial Tears Study in Mild to Moderate Dry Eye Patients

Dry Eye Clinical Trial

Official title:
Artificial Tears Study in Mild to Moderate Dry Eye Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00607776
Other study ID # PEGT-104-9582
Secondary ID
Status Completed
Phase Phase 2
First received December 19, 2007
Last updated February 5, 2008
Start date January 2007
Est. completion date April 2007

Study information
Verified date January 2008
Source Abbott Medical Optics
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The mean change in the subjective comfort score from baseline of the test group is at least 2.0 units less than that of the control group.

Recruitment information / eligibility
Status Completed
Enrollment 110
Est. completion date April 2007
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Mild to moderate dry eye

- over 18

Exclusion Criteria:

- No concurrent ocular disease or meds

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• (9587X) Blink Tears, classified as an OTC Drug with the active ingredient being plyethylene glycol 400
Drops
• Systane
Drops

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Abbott Medical Optics

Outcome
Type Measure Description Time frame Safety issue
Primary Subjective ocular comfort 1 Month No
Secondary Vision quality 1 Month No
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