A 2-week Clinical Comparison of SYSTANE® Ultra to Sensitive Eyes Rewetting Drops in Contact Lens Wearing Patients.
Completed
- Conditions
- Dry Eye
- Registration Number
- NCT00769665
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 47
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).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adverse Events and Visual Acuity 2 weeks
- Secondary Outcome Measures
Name Time Method