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

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

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®.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: Multi-Purpose Disinfecting Solution (OPTI-FREE RepleniSH); Device: Contact Lenses

• Study Type: Interventional
• Enrollment (Actual): 114
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Fort Worth, Texas, United States, 76134
      • Alcon Call Center for Trial Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: OPTI-FREE RepleniSH®; Device: Contact Lenses; Contact lenses per participant's habitual prescription removed nightly for cleaning and disinfecting.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comfort Ratings at Baseline	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.	Baseline (Day 0)
Comfort Ratings at 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.	30 days

Collaborators and Investigators

• Sponsor: Alcon Research

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): October 1, 2008
• Study Completion (Actual): October 1, 2008

Study Registration Dates

• First Submitted: October 7, 2008
• First Submitted That Met QC Criteria: October 13, 2008
• First Posted (Estimate): October 15, 2008

Study Record Updates

• Last Update Posted (Estimate): September 7, 2012
• Last Update Submitted That Met QC Criteria: August 31, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: contact lenses; contact lens solution; OPTI-FREE RepleniSH
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: SMA-08-14