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

Completed

• Conditions: Dry Eye
• Interventions: Other: Systane Ultra; Other: Sensitive Eyes Rewetting Drops

• 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

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-10-07
• Study First Submitted QC: 2008-10-08
• Study First Posted: 2008-10-09
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-31
• Last Update Posted: 2012-02-02

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

Arm && Interventions

Group	Intervention	Description
Systane Ultra	Systane Ultra	Systane Ultra
Sensitive Eyes	Sensitive Eyes Rewetting Drops	Sensitive Eyes

Primary Outcome Measures

Name	Time	Method
Adverse Events and Visual Acuity	2 weeks