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

Alcon

Status: Completed

Conditions: Myopia

Treatments: Device: Contact Lenses; Device: Multi-Purpose Disinfecting Solution (OPTI-FREE RepleniSH)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00772707

SMA-08-14

Details and patient eligibility

About

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®.

Enrollment: 114 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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114 participants in 1 patient group

Opti-Free Replenish

Experimental group

Description:

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

Treatment:

Device: Contact Lenses

Device: Multi-Purpose Disinfecting Solution (OPTI-FREE RepleniSH)