Evaluation of an Investigational Multi-Purpose Disinfecting Solution for the Care of Soft Contact Lenses in Symptomatic Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

362 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2005-02-28

Brief Summary

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The objective of the study was to clinically evaluate the safety and effectiveness of a new multi-purpose disinfecting solution for soft contact lenses in patients who experience discomfort with their contact lenses.

Detailed Description

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Conditions

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Contact Lens Care

Keywords

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Contact Lens Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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OptiFree Multi-Purpose Disinfecting Solution

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Symptomatic for contact lens related discomfort at the end of the lens wearing day.
* Successful daily wear of FDA Group IV lenses on a two-week or longer replacement schedule for at least two weeks.
* Use of a multi-purpose solution only as the pre-study care regimen for at least one month (rewetting drops use is also acceptable).
* Successful lens wear for at least 4 hours per day.
* Vision correctable to 20/30.
* Normal eyes - no current ocular abnormalities that prevent successful contact lens wear.
* No corneal surgery within the past 12 months.
* No systemic disease that affects that eye or that could be worsened by the use of contact lenses or solutions.
* No over-the-counter or prescription ocular medication.
* No enrollment in another clinical study within 30 days prior to enrollment.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Leslie Napier

Role: STUDY_DIRECTOR

Alcon Research

Locations

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Highlands Ranch

Highlands Ranch, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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C-04-09

Identifier Type: -

Identifier Source: org_study_id