A 2-week Clinical Comparison of SYSTANE® Ultra to Sensitive Eyes Rewetting Drops in Contact Lens Wearing Patients. | NCT00769665 | Trialant
CompletedObservationalUpdated Feb 2, 2012
A 2-week Clinical Comparison of SYSTANE® Ultra to Sensitive Eyes Rewetting Drops in Contact Lens Wearing Patients.
ClinicalTrials.gov ID
NCT00769665
Lead Sponsor
Alcon ResearchINDUSTRY
Overall Status
Completed
Study Type
Observational
Enrollment
47Actual
Last Update Posted
Feb 2, 2012Estimated
Start Date
Oct 2008
Primary Completion Date
Jan 2009Actual
Completion Date
Jan 2009Actual
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.
Dry Eye
Systane Ultra
Sensitive Eyes Rewetting Drops
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
Yes
Eligibility Criteria
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).