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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00769665
First received: October 7, 2008
Last updated: January 31, 2012
Last verified: January 2012

October 7, 2008
January 31, 2012
October 2008
January 2009   (final data collection date for primary outcome measure)
Adverse Events and Visual Acuity [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00769665 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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A 2-week Clinical Comparison of SYSTANE® Ultra to Sensitive Eyes Rewetting Drops in Contact Lens Wearing Patients.
Not Provided

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
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Non-Probability Sample

community sample

Dry Eye
  • Other: Systane Ultra
    Re-wetting ocular eye drop
  • Other: Sensitive Eyes Rewetting Drops
    Re-wetting ocular eye drop
  • Systane Ultra
    Systane Ultra
    Intervention: Other: Systane Ultra
  • Sensitive Eyes
    Sensitive Eyes
    Intervention: Other: Sensitive Eyes Rewetting Drops
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
47
January 2009
January 2009   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00769665
SMA-08-15
No
Alcon Research
Alcon Research
Not Provided
Not Provided
Alcon Research
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP