NCT00769665

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2008

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

October 7, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 9, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

February 2, 2012

Status Verified

January 1, 2012

Enrollment Period

3 months

First QC Date

October 7, 2008

Last Update Submit

January 31, 2012

Conditions

Dry Eye

Keywords

Dry Eyere-wetting drops

Outcome Measures

Primary Outcomes (1)

  • Adverse Events and Visual Acuity

    2 weeks

Study Arms (2)

Systane Ultra

Systane Ultra

Other: Systane Ultra

Sensitive Eyes

Sensitive Eyes

Other: Sensitive Eyes Rewetting Drops

Interventions

Systane UltraOTHER

Re-wetting ocular eye drop

Systane Ultra
Sensitive Eyes Rewetting DropsOTHER

Re-wetting ocular eye drop

Sensitive Eyes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

community sample

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2008

First Posted

October 9, 2008

Study Start

October 1, 2008

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

February 2, 2012

Record last verified: 2012-01