Acute Clinical Evaluation of Multi-purpose Solutions (MPS) in Soft Contact Lens Wearers

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: Contact lens multi-purpose solution; Other: Saline/blister pack solution; Device: Contact lenses

• Registration Number: NCT00929487
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study was to clinically evaluate lens care solutions used with soft contact lenses.

Detailed Description

This study was conducted as a series of ten smaller studies in three countries using commercially available contact lens solutions per each country, ie, United Kingdom, France, and the Philippines. In each study, participants were assessed after use of up to 5 products (with one always being a control saline/blister pack solution) in randomized order in conjunction with one of the silicone hydrogel contact lenses. A total of 278 participants were enrolled in the 10 studies.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-06-25
• Study First Submitted QC: 2009-06-26
• Study First Posted: 2009-06-29
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-06
• Last Update Posted: 2012-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 278

Inclusion Criteria

• Have read, understood, signed, and dated the written Informed Consent.
• Be an adapted and successful soft contact lens wearer on a daily wear basis for at least two weeks.
• Vision correctable to at least 20/30 Snellen.
• Other protocol-defined inclusion criteria may apply.

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Exclusion Criteria

• Topical ocular medication use.
• History of hypersensitivity to any component of the study contact lens care systems.
• Any slit-lamp finding of abnormal nature at the baseline visit assessment of each study period.
• Pregnant, lactating, or planning a pregnancy.
• Other protocol-defined exclusion criteria may apply.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Contact lens solution #1	Contact lens multi-purpose solution	-
Contact lens solution #1	Contact lenses	-
Contact lens solution #2	Contact lens multi-purpose solution	-
Contact lens solution #2	Contact lenses	-
Contact lens solution #3	Contact lens multi-purpose solution	-
Contact lens solution #3	Contact lenses	-
Contact lens solution #4	Contact lens multi-purpose solution	-
Contact lens solution #4	Contact lenses	-
Saline/blister pack solution	Saline/blister pack solution	-
Saline/blister pack solution	Contact lenses	-

Primary Outcome Measures

Name	Time	Method
Corneal Staining	2 hours

Secondary Outcome Measures

Name	Time	Method
Subjective Comfort	2 hours

Trial Locations

Locations (1)

Visioncare Research, Ltd.; 🇬🇧 Farnham, Surrey, United Kingdom