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

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Multi-Purpose Disinfecting Solution (OPTI-FREE RepleniSH)
Contact Lenses
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia focused on measuring contact lens solution, OPTI-FREE RepleniSH, contact lenses

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Alcon Call Center for Trial Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Opti-Free Replenish

Arm Description

Multi-purpose contact lens solution for cleaning and disinfecting study contact lenses used on a daily basis for 30 days.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
October 7, 2008
Last Updated
August 31, 2012
Sponsor
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT00772707
Brief Title
A Multi-Center Investigation of Patient Acceptability of OPTI-FREE RepleniSH® Multi-Purpose Disinfecting Solution (MPDS)
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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®.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
Keywords
contact lens solution, OPTI-FREE RepleniSH, contact lenses

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
114 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Opti-Free Replenish
Arm Type
Experimental
Arm Description
Multi-purpose contact lens solution for cleaning and disinfecting study contact lenses used on a daily basis for 30 days.
Intervention Type
Device
Intervention Name(s)
Multi-Purpose Disinfecting Solution (OPTI-FREE RepleniSH)
Other Intervention Name(s)
OPTI-FREE RepleniSH®
Intervention Description
OPTI-FREE RepleniSH® used according to product labeled instructions for cleaning and disinfecting study contact lenses, 30 days.
Intervention Type
Device
Intervention Name(s)
Contact Lenses
Intervention Description
Contact lenses per participant's habitual prescription removed nightly for cleaning and disinfecting.
Primary Outcome Measure Information:
Title
Comfort Ratings at Baseline
Description
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.
Time Frame
Baseline (Day 0)
Title
Comfort Ratings at 30 Days
Description
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.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Alcon Call Center for Trial Locations
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76134
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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