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

NCT ID: NCT01484938

Last Updated: 2012-10-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

175 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2011-05-31

Brief Summary

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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).

Detailed Description

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Conditions

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Refractive Error

Keywords

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Soft contact lenses Multi-purpose solution Corneal staining

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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OPTI-FREE

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

Group Type EXPERIMENTAL

OPTI-FREE PureMoist

Intervention Type DEVICE

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

Interventions

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OPTI-FREE PureMoist

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

Intervention Type DEVICE

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jami R Kern

Role: STUDY_DIRECTOR

Alcon Research

Locations

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Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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C-10-017

Identifier Type: -

Identifier Source: org_study_id