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

NCT01484938 | Completed Results

• 1 other identifier: C-10-017
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Refractive Error

Keywords

Soft contact lenses; Multi-purpose solution; Corneal staining

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

OPTI-FREE

EXPERIMENTAL

OPTI-FREE PureMoist multi-purpose contact lens solution used for cleaning, rinsing, disinfecting/storing, and reinserting contact lenses, per protocol-specified regimen

Device: OPTI-FREE PureMoist

Interventions

OPTI-FREE PureMoist DEVICE

Commercially marketed multi-purpose contact lens solution for cleaning, rinsing, disinfecting/storing, and reinserting contact lenses

OPTI-FREE

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (1)

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, 76134, United States

Location

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

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

800-862-5266

Study Officials

• Jami R Kern

  Alcon Research

  STUDY DIRECTOR

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: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2011
• First Posted: December 5, 2011
• Study Start: February 1, 2011
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: October 10, 2012
• Results First Posted: October 8, 2012

Record last verified: 2012-10

Locations

US (1)