Efficacy Evaluation of Systane® Ultra to Reduce Visual Degradation

This study has been completed.

First Received: July 13, 2009 Last Updated: July 29, 2009 History of Changes

Sponsored by:	Alcon Research
Information provided by:	Alcon Research
ClinicalTrials.gov Identifier:	NCT00938951

Purpose

The primary objective of this study is to compare visual degradation in a stressed (forced stare) environment in patients before and after acute administration of Systane Ultra.

Condition	Intervention	Phase
Dry Eye Symptoms Visual Degradation	Drug: Systane® Ultra	Phase IV

Study Type:	Interventional
Study Design:	Supportive Care, Non-Randomized, Open Label, Single Group Assignment

Further study details as provided by Alcon Research:

Primary Outcome Measures:

Percent change from baseline of time of visual clarity following acute instillation of test article at a single visit. [ Time Frame: Baseliine and 5 minutes post instillation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Adverse event occurence [ Time Frame: Post instillation of test article ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	July 2009
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Systane® Ultra: Experimental Systane® Ultra	Drug: Systane® Ultra Systane® Ultra

Eligibility

Ages Eligible for Study:	18 Years to 42 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Patients must answer "Yes" to the study eligibility question, and they must be healthy and may not have a medical problem that requires a medication.
Patients must have a best-corrected visual acuity of 20/20 in both eyes, and a tear break-up time (TBUT) that is greater than or equal to 10 seconds at the baseline visit.

Exclusion Criteria:

Patients cannot use of any prescription or OTC medication for one month prior to the study, unless the PI determines that the medication would not impact the study outcomes.
Patients cannot use any ocular medications for two weeks prior to the study (including artificial tears).
Patients cannot have a prior history of dry eye or have a known sensitivity to the study medications.
Patients can not participate in any other ophthalmic drug or device clinical trial within 30 days of the baseline visit.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00938951

Locations

United States, Texas
Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134

Sponsors and Collaborators

Alcon Research

More Information

No publications provided

Responsible Party:	Alcon Research ( Joseph Griffin/Manager, Scientific Market Affairs )
Study ID Numbers:	SMA-09-22
Study First Received:	July 13, 2009
Last Updated:	July 29, 2009
ClinicalTrials.gov Identifier:	NCT00938951 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Alcon Research:

Dry Eye
Visual Degradation

ClinicalTrials.gov processed this record on September 11, 2009