Lens Wearing Experience and Biocompatibility of a Marketed Multi-Purpose Disinfecting Solution in Silicone Hydrogel and Soft Contact Lens Wearers

Refractive Error Clinical Trial

Official title:

Lens Wearing Experience and Biocompatibility of a Marketed Multi-Purpose Disinfecting Solution in Silicone Hydrogel and Soft Contact Lens Wearers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01484938
• Other study ID #: C-10-017
• Status: Completed
• Phase: N/A
• First received: December 1, 2011
• Last updated: October 5, 2012
• Start date: February 2011
• Est. completion date: May 2011

Study information

• Verified date: October 2012
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Independent Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to describe mean differences in corneal staining (type and area) for OPTI-FREE PureMoist Multi-Purpose Disinfecting Solution (MPDS) at Day 30 compared to Baseline (Day 0).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years or older

• Soft contact lens wear on a daily wear basis

• Able to wear contact lenses for at least 8 hours

• Generally healthy and have normal ocular health

• Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

• No use of additional lens cleaners

• No known sensitivities to any ingredient in the test article

• No history of ocular surgery/trauma within the last six months

• Other protocol-defined exclusion criteria may apply

Study Design

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

Related Conditions & MeSH terms

• Refractive Error
• Refractive Errors

Intervention

Device:
• OPTI-FREE PureMoist
Commercially marketed multi-purpose contact lens solution for cleaning, rinsing, disinfecting/storing, and reinserting contact lenses

Locations

Country	Name	City	State
United States	Contact 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	Mean Change From Baseline (Day 0) in Average Corneal Staining Area at Day 30	Percentage corneal staining was assessed by the investigator for each of five regions of the cornea; i.e., four quadrants plus central. The investigator instilled flourescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and yellow filter. Percentage corneal staining was recorded in increments of ten, and the percentages of the five regions were averaged together.	Baseline (Day 0), Day 30	Yes
Primary	Mean Change From Baseline (Day 0) in Total Corneal Staining Type at Day 30	Corneal staining type was assessed by the investigator for each of five regions of the cornea, i.e., four quadrants plus central. The investigator instilled flourescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and yellow filter. Corneal staining type was recorded on a 5-point scale for each region: 0=none; 1=micropunctate; 2=macropunctate; 3=coalesced macropunctate; 4=patch (>/= 1 mm). The five regions were summed, for a summed total range of 0-20.	Baseline (Day 0), Day 30	Yes