NCT00929487

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

Acute Clinical Evaluation of MPS in Soft Contact Lens Wearers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 278 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myopia

Interventions

Type	Name	Description
DEVICE	Contact lens multi-purpose solution	Lens care solutions CE-marked for intended use. A fresh pair of contact lenses was soaked overnight in the test contact lens solution and a pre-cycled lens case prior to study visit, then worn for two hours on the day of the study visit. Up to four solutions were evaluated in randomized order with the same brand of contact lenses, and a minimum of 12 hours of no lens wear separated each wear period.
OTHER	Saline/blister pack solution	A fresh pair of contact lenses was soaked overnight in saline prior to study visit or was inserted directly from the blister pack, then worn for two hours on the day of the study visit.
DEVICE	Contact lenses	CE-marked silicone hydrogel contact lenses soaked overnight for at least 10 hours prior to the study visit, then worn for two hours on the day of the study visit. A fresh pair of the same brand of contact lenses was used for each overnight soak (ie, 4 solutions plus saline/blister pack solution), and a minimum of 12 hours separated each wear period.

Timeline

• Start date: 2009-05-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2009-06-29
• Last updated: 2012-09-10

Locations

1 site across 1 country: United Kingdom