Status:
COMPLETED
A 2-week Clinical Comparison of SYSTANE® Ultra to Sensitive Eyes Rewetting Drops in Contact Lens Wearing Patients.
Lead Sponsor:
Alcon Research
Conditions:
Dry Eye
Eligibility:
All Genders
18+ years
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.
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
October 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT00769665
Start Date
October 1 2008
End Date
January 1 2009
Last Update
February 2 2012
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