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

Alcon

Status: Completed

Conditions: Myopia

Treatments: Other: Saline/blister pack solution; Device: Contact lenses; Device: Contact lens multi-purpose solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT00929487

SMA-09-14/RDG-11-152

Details and patient eligibility

About

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

Full 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.

Enrollment: 278 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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278 participants in 5 patient groups

Contact lens solution #1

Experimental group

Treatment:

Device: Contact lens multi-purpose solution

Device: Contact lenses

Contact lens solution #2

Experimental group

Treatment:

Device: Contact lens multi-purpose solution

Device: Contact lenses

Contact lens solution #3

Experimental group

Treatment:

Device: Contact lens multi-purpose solution

Device: Contact lenses

Contact lens solution #4

Experimental group

Treatment:

Device: Contact lens multi-purpose solution

Device: Contact lenses

Saline/blister pack solution

Active Comparator group

Treatment:

Device: Contact lenses

Other: Saline/blister pack solution