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

Myopia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00772707
• Other study ID #: SMA-08-14
• Status: Completed
• Phase: N/A
• First received: October 7, 2008
• Last updated: August 31, 2012
• Start date: September 2008
• Est. completion date: October 2008

Study information

• Verified date: August 2012
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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®.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myopia

Intervention

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

Locations

Country	Name	City	State
United States	Alcon Call Center for Trial Locations	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	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	No