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A 30 Day, Multi-Centered, Open Label Study To Determine Comfort and Overall Contact Lens Wearing Experience Using Optifree RepleniSH MPDS vs. COMPLETE MPS Easy Rub or ReNu MultiPlus in Daily Wear Soft Contact Lens Patients.
This study is currently recruiting participants.
Verified by Alcon Research, October 2008
Sponsored by: Alcon Research
Information provided by: Alcon Research
ClinicalTrials.gov Identifier: NCT00772707
  Purpose

To demonstrate that with proper use, current successful full- time daily wear soft contact lens wearers using competitive multi-purpose solutions will note improved comfort with Optifree RepleniSH®


Condition Intervention Phase
Contact Lens Wear
Device: Opti-Free RepleniSH
Phase IV

MedlinePlus related topics: Eye Wear
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Patient Questionnaire responses [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Visual Acuity, Adverse Events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: September 2008
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Opti-Free RepliniSH
Device: Opti-Free RepleniSH
Contact Lens Cleaning solution

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Participants must be between 18 and 65 years of age.
  2. Must wear daily wear soft contact lenses a minimum of 8 hours per day,7 days a week.
  3. Must be wearing a planned replacement soft lens in a 2 week or monthly replacement modality.
  4. Must be using either COMPLETE MPS Easy Rub or ReNu MultiPlus brand solution for at least 30 continuous days prior to enrollment.
  5. Must be free of any contact lens related symptoms with regard to comfort and vision throughout their wearing hours prior to enrollment, with the exception of EOD dryness not limiting all day wear.
  6. Must have best corrected distance visual acuity, with contact lenses, of 20/30 or better in each eye.
  7. Must be willing to maintain pre-enrollment systemic medication regimens during the study.
  8. Must be willing to not use any topical medications or rewetting drops during the 30 day clinical trial duration.

Exclusion Criteria:

  1. Has used any topical medication or rewetting drops for 7 days prior to enrollment.
  2. Achieves best visual correction by monovision.
  3. Has modified their systemic medications within 30 days prior to enrollment.
  4. Has switched brands of cosmetics during the 30 days prior to the study.
  5. Has a history of allergy to any study product ingredients.
  6. Is unwilling or unable to meet the study visit timeline.
  7. 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00772707

Contacts
Contact: Alcon Call Center 1-888-451-3937

Locations
United States, Texas
Alcon Call Center for Trial Locations Recruiting
Fort Worth, Texas, United States, 76134
Contact: Alcon Call Center     888-451-3937        
Sponsors and Collaborators
Alcon Research
  More Information

Responsible Party: Alcon Research ( Dr. Joseph Griffin, Ph.D., D.A.B.T.\Study Manager, Consumer Products )
Study ID Numbers: SMA-08-14
Study First Received: October 7, 2008
Last Updated: October 13, 2008
ClinicalTrials.gov Identifier: NCT00772707  
Health Authority: United States: Institutional Review Board

Keywords provided by Alcon Research:
Contact lens solution
opti-free
cleaning solution

ClinicalTrials.gov processed this record on January 14, 2009