Skip to main content
OpenTrials
Completed

NCT Number: NCT00772707

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

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®.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alcon Call Center for Trial Locations

Fort Worth, Texas, 76134, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants must be between 18 and 65 years of age.
  • Must wear daily wear soft contact lenses a minimum of 8 hours per day,7 days a week.
  • Must be wearing a planned replacement soft lens in a 2 week or monthly replacement modality.
  • 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.
  • 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.
  • Must have best corrected distance visual acuity, with contact lenses, of 20/30 or better in each eye.
  • Must be willing to maintain pre-enrollment systemic medication regimens during the study.
  • Must be willing to not use any topical medications or rewetting drops during the 30 day clinical trial duration.
  • Other protocol-defined inclusion criteria may apply.

Exclusion criteria

  • Has used any topical medication or rewetting drops for 7 days prior to enrollment.
  • Achieves best visual correction by monovision.
  • Has modified their systemic medications within 30 days prior to enrollment.
  • Has switched brands of cosmetics during the 30 days prior to the study.
  • 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.
  • Other protocol-defined exclusion criteria may apply.

Treatment and study plan

Multi-Purpose Disinfecting Solution (OPTI-FREE RepleniSH)

Device

OPTI-FREE RepleniSH® used according to product labeled instructions for cleaning and disinfecting study contact lenses, 30 days.

Other names: OPTI-FREE RepleniSH®

Contact Lenses

Device

Contact lenses per participant's habitual prescription removed nightly for cleaning and disinfecting.

Primary outcomes

  1. Comfort Ratings at Baseline

    Time frame: Baseline (Day 0)

    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.

  2. Comfort Ratings at 30 Days

    Time frame: 30 days

    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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Oct 15, 2008
Registry last updated
Sep 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.