A 2-week Clinical Comparison of SYSTANE® Ultra to Sensitive Eyes Rewetting Drops in Contact Lens Wearing Patients.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00769665
Recruitment Status : Completed
First Posted : October 9, 2008
Last Update Posted : February 2, 2012
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
To evaluate safety with the use of Systane Ultra in contact lens wearers. A comparison to a currently marketed contact lens rewetting drop will be included as a control.

Condition or disease Intervention/treatment
Dry Eye Other: Systane Ultra Other: Sensitive Eyes Rewetting Drops

Study Type : Observational
Actual Enrollment : 47 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : October 2008
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Eye Wear
Drug Information available for: Systane
U.S. FDA Resources

Group/Cohort Intervention/treatment
Systane Ultra
Systane Ultra
Other: Systane Ultra
Re-wetting ocular eye drop
Sensitive Eyes
Sensitive Eyes
Other: Sensitive Eyes Rewetting Drops
Re-wetting ocular eye drop

Primary Outcome Measures :
  1. Adverse Events and Visual Acuity [ Time Frame: 2 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
community sample

Inclusion Criteria:

  • Participants must be between 18 and 65 years of age.
  • Provide written Informed Consent.
  • Must be wearing a planned replacement soft lens in a 2 week or monthly replacement modality, or a Rigid Gas Permeable (RGP) contact Lens
  • Must have best corrected distance visual acuity, with contact lenses, of 20/30 or better in each eye.
  • Sodium fluorescein (NaFl) corneal staining score sum of < 2 in both eyes (NEI scoring system).
  • Must be willing to maintain pre-enrollment systemic medication regimens during the study.
  • Must be available for study visits and to fill out study questionnaires.

Exclusion Criteria:

  • Has modified their systemic medications within 30 days prior to enrollment.
  • Has a history of allergy to any study product ingredients
  • Is unwilling or unable to meet the study visit timeline.
  • Has any active corneal, eyelid or other anterior segment inflammation or infection, which, in the opinion of the Investigator, would adversely affect successful contact lens wear.
  • Is currently using any topical eye medications (not including rewetting drops, artificial tear products or Restasis).

Responsible Party: Alcon Research Identifier: NCT00769665     History of Changes
Other Study ID Numbers: SMA-08-15
First Posted: October 9, 2008    Key Record Dates
Last Update Posted: February 2, 2012
Last Verified: January 2012

Keywords provided by Alcon Research:
Dry Eye
re-wetting drops