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

Dry Eye Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00769665
• Other study ID #: SMA-08-15
• Status: Completed
• Phase: N/A
• First received: October 7, 2008
• Last updated: January 31, 2012
• Start date: October 2008
• Est. completion date: January 2009

Study information

• Verified date: January 2012
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dry Eye

Intervention

Other:
• Systane Ultra
Re-wetting ocular eye drop
• Sensitive Eyes Rewetting Drops
Re-wetting ocular eye drop

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events and Visual Acuity		2 weeks	Yes