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

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00769665
• Collaborator: (none)
• Enrollment: 47
• Duration (Months): 3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye	Other: Systane Ultra; Other: Sensitive Eyes Rewetting Drops

Study Design

• Study Type: Observational
• Actual Enrollment: 47 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Study Start Date: Oct 1, 2008
• Actual Primary Completion Date: Jan 1, 2009
• Actual Study Completion Date: Jan 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Adverse Events and Visual Acuity [2 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

No locations specified.

Sponsors and Collaborators

• Alcon Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT00769665
• Other Study ID Numbers: SMA-08-15
• First Posted: Oct 9, 2008
• Last Update Posted: Feb 2, 2012
• Last Verified: Jan 1, 2012

• Keywords provided by Alcon Research: Dry Eye; re-wetting drops
• Additional relevant MeSH terms: Dry Eye Syndromes

Study Results

No Results Posted as of Feb 2, 2012