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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00769665
First received: October 7, 2008
Last updated: January 31, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention
Dry Eye
Other: Systane Ultra
Other: Sensitive Eyes Rewetting Drops

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Adverse Events and Visual Acuity [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 47
Study Start Date: October 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Systane Ultra
Systane Ultra
Other: Systane Ultra
Re-wetting ocular eye drop
Sensitive Eyes
Sensitive Eyes
Other: Sensitive Eyes Rewetting Drops
Re-wetting ocular eye drop

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

community sample

Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00769665     History of Changes
Other Study ID Numbers: SMA-08-15
Study First Received: October 7, 2008
Last Updated: January 31, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Alcon Research:
Dry Eye
re-wetting drops

ClinicalTrials.gov processed this record on September 18, 2014