Dry Eye
Conditions
Keywords
Dry Eye, re-wetting drops
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.
Interventions
OTHERSystane Ultra
Re-wetting ocular eye drop
Re-wetting ocular eye drop
Sponsors
Alcon Research
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Events and Visual Acuity | 2 weeks |
Outcome results
None listed