A Multi‐Center Investigation of Patient Acceptability of OPTI‐FREE RepleniSH® Multi-Purpose Disinfecting Solution (MPDS)
This study has been completed.
Sponsor:
Alcon Research
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
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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:
- 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.
Contacts and Locations
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 May 22, 2013