A Multi‐Center Investigation of Patient Acceptability of OPTI‐FREE RepleniSH® Multi-Purpose Disinfecting Solution (MPDS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00772707
First received: October 7, 2008
Last updated: August 31, 2012
Last verified: August 2012
  Purpose

The purpose of this study was to demonstrate that current successful fulltime daily wear soft contact lens wearers using competitive multi-purpose solutions will note improved comfort when using OPTI-FREE RepleniSH®.


Condition Intervention
Myopia
Device: Multi-Purpose Disinfecting Solution (OPTI-FREE RepleniSH)
Device: Contact Lenses

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A 30 Day, Multi‐Centered, Open Label Study To Determine Comfort and Overall Contact Lens Wearing Experience Using OPTI‐FREE RepleniSH® MPDS as Compared to COMPLETE®MPS Easy Rub™ or ReNu MultiPlus® in Daily Wear Soft Contact Lens Patients

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Comfort Ratings at Baseline [ Time Frame: Baseline (Day 0) ] [ Designated as safety issue: No ]
    Prior to any ocular assessments at the visit, comfort ratings were collected on a questionnaire using 5-point Likert scale, with 1=Strongly Agree, 1=Agree, 3=Neutral, 4=Disagree, 5=Strongly Disagree. The percentage of participants responding with "Strongly Agree" or "Agree" for each question is presented.

  • Comfort Ratings at 30 Days [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Prior to any ocular assessments at the visit, comfort ratings were collected on a questionnaire using 5-point Likert scale, with 1=Strongly Agree, 1=Agree, 3=Neutral, 4=Disagree, 5=Strongly Disagree. The percentage of participants responding with "Strongly Agree" or "Agree" for each question is presented.


Enrollment: 114
Study Start Date: September 2008
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Opti-Free Replenish
Multi-purpose contact lens solution for cleaning and disinfecting study contact lenses used on a daily basis for 30 days.
Device: Multi-Purpose Disinfecting Solution (OPTI-FREE RepleniSH)
OPTI‐FREE RepleniSH® used according to product labeled instructions for cleaning and disinfecting study contact lenses, 30 days.
Other Name: OPTI-FREE RepleniSH®
Device: Contact Lenses
Contact lenses per participant's habitual prescription removed nightly for cleaning and disinfecting.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 Multi-Purpose Solution (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 end-of-day 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.
  9. Other protocol-defined inclusion criteria may apply.

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.
  8. Other protocol-defined exclusion criteria may apply.
  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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00772707

Locations
United States, Texas
Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00772707     History of Changes
Other Study ID Numbers: SMA-08-14
Study First Received: October 7, 2008
Results First Received: August 1, 2012
Last Updated: August 31, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Alcon Research:
contact lens solution
OPTI-FREE RepleniSH
contact lenses

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases
Contact Lens Solutions
Disinfectants
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014