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Comparison of 3 Novel Contact Lens Solutions on the Basal Lamina

NCT ID: NCT00691457

Last Updated: 2012-10-01

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

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2009-01-31

Brief Summary

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Three arm study comparing three novel contact lens solutions.

Detailed Description

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Conditions

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Contact Lens Solution

Keywords

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Contact lens solution confocal microscope

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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1

Opti-Free contact lens solution

Group Type EXPERIMENTAL

Opti-Free contact lens solution

Intervention Type DEVICE

Solution

2

ReNu Multiplus contact lens solution

Group Type ACTIVE_COMPARATOR

ReNu Multiplus contact lens solution

Intervention Type DEVICE

Solution

3

Clear Care contact lens solution

Group Type ACTIVE_COMPARATOR

Clear Care contact lens solution

Intervention Type DEVICE

Solution

Interventions

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Opti-Free contact lens solution

Solution

Intervention Type DEVICE

ReNu Multiplus contact lens solution

Solution

Intervention Type DEVICE

Clear Care contact lens solution

Solution

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Stable distance contact lens prescription between -0.50 D and 9.00 D and astigmatism less than or equal to -1.00 D cylindrical (cyl).
* Stable correction is defined as longer than six months.
* Worn a single brand of disposable silicone hydrogel contact lenses successfully (i.e., without complications or discomfort) for a minimum of six months

Exclusion:

* Known sensitivity to the contact lens disinfecting solutions or fluorescein dye.
* Any systemic or ocular disease that could affect contact lens wear.
* Women who are pregnant or lactating.
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

Locations

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Virginia Beach, VA

Virginia Beach, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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SMA-08-09

Identifier Type: -

Identifier Source: org_study_id