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

NCT00772707 | Completed Results

• 1 other identifier: SMA-08-14
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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®.

Conditions

Myopia

Keywords

contact lens solution; OPTI-FREE RepleniSH; contact lenses

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Opti-Free Replenish

EXPERIMENTAL

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); Device: Contact Lenses

Interventions

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.

Also known as: OPTI-FREE RepleniSH®

Opti-Free Replenish

Contact Lenses DEVICE

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

Opti-Free Replenish

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (1)

Alcon Call Center for Trial Locations

Fort Worth, Texas, 76134, United States

Location

MeSH Terms

Conditions

Myopia

Interventions

Contact Lenses

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Lenses; Optical Devices; Equipment and Supplies

Results Point of Contact

• Title: Jami Kern, Ph.D.
• Organization: Alcon Global Medical Affairs

1-888-451-3937

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2008
• First Posted: October 15, 2008
• Study Start: September 1, 2008
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: September 7, 2012
• Results First Posted: September 3, 2012

Record last verified: 2012-08

Locations

US (1)