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

Myopia Clinical Trial

Official title:

Acute Clinical Evaluation of MPS in Soft Contact Lens Wearers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00929487
• Other study ID #: SMA-09-14/RDG-11-152
• Status: Completed
• Phase: N/A
• First received: June 25, 2009
• Last updated: September 6, 2012
• Start date: May 2009
• Est. completion date: May 2012

Study information

• Verified date: September 2012
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics CommitteeFrance: Institutional Ethical CommitteePhilippines: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 278
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Myopia

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Visioncare Research, Ltd.	Farnham	Surrey

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corneal Staining		2 hours	No
Secondary	Subjective Comfort		2 hours	No