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

Alcon

Status

Completed

Conditions

Dry Eye

Treatments

Other: Sensitive Eyes Rewetting Drops

Other: Systane Ultra

Study type

Observational

Funder types

Industry

Identifiers

NCT00769665

SMA-08-15

Details and patient eligibility

About

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.

Enrollment

47 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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).