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

NCT ID: NCT00772707

Last Updated: 2012-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2008-10-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Opti-Free Replenish

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

Group Type: EXPERIMENTAL

Multi-Purpose Disinfecting Solution (OPTI-FREE RepleniSH)

Intervention Type: DEVICE

OPTI-FREE RepleniSH® used according to product labeled instructions for cleaning and disinfecting study contact lenses, 30 days.

Contact Lenses

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

Contact Lenses

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

Intervention Type: DEVICE

Other Intervention Names

OPTI-FREE RepleniSH®

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Alcon Call Center for Trial Locations

Fort Worth, Texas, United States

Countries

United States

Other Identifiers

SMA-08-14

Identifier Type: -

Identifier Source: org_study_id