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NCT01086774 Clinical Trial

Efficacy of Systane Balance to Stabilize the Tear Film in Dry Eye Subjects

Dry Eye Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01086774
Other study ID # SMA-09-39
Secondary ID
Status Completed
Phase Phase 4
First received March 12, 2010
Last updated January 31, 2012
Start date July 2010

Study information
Verified date January 2012
Source Alcon Research
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Evaluation of the optical effects of Systane Ultra

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date
Est. primary completion date November 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Age 18 years or more.

2. Subjects must have Tear Break Up Time (TBUT) < 5 seconds

3. Subjects must have a maximum blink interval (MBI) < 10 seconds

4. Subjects must be willing to comply with all study requirements.

5. Subjects must understand, sign and be given a copy of the written Informed Consent form.

Exclusion Criteria:

1. Subjects for whom both eyes do not meet all inclusion criteria and either eye meets exclusion criteria

2. Subjects who are pregnant, lactating or planning to be pregnant during the course of the study

3. Subjects with known sensitivity to planned study concomitant medications

4. Subjects participating in any other ophthalmic drug or device clinical trial within 30 days of this clinical investigation.

5. Use of ocular drugs, other than study medications, during the study and within 14 days prior to study entry or any other ocular medication

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Other:
• Systane Ultra Lubricant Eye Drops
Single drop in both eyes

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Alcon Research

Outcome
Type Measure Description Time frame Safety issue
Primary Improvement in maximum blink interval (MBI) 1 day No
Secondary Tear film stability and contrast sensitivity 1 day No
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