Ocular Responses to Short and Long-term Lens Wear

Ametropia Clinical Trial

Official title:

Ocular Responses to Acute and Chronic Lens Wear

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00722891
• Other study ID #: P/289/07/B
• Status: Completed
• Phase: N/A
• Start date: July 2008
• Est. completion date: September 2009

Study information

• Verified date: November 2019
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to determine whether ocular surface sensitivity to pneumatic, mechanical and chemical stimulation would be affected by the use of the combination of a specific silicone hydrogel lens material with two lens care products over a four week period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 17 Years and older

Eligibility

Inclusion Criteria:

• Is at least 17 years old and has full legal capacity to volunteer;

• Is correctable to a visual acuity of 6/7.5 (20/25) or better (both eyes) with their habitual vision correction;

• Is a current soft lens wearer and wears contact lenses six or more days/week;

• Has clear corneas and no active ocular disease.

Exclusion Criteria:

• Has any clinically significant blepharitis or dry eye;

• Has undergone corneal refractive surgery;

• Is aphakic;

• Has any active ocular disease;

• Has any systemic disease affecting ocular health;

• Is using any systemic or topical medications that may affect ocular health;

Related Conditions & MeSH terms

• Ametropia
• Refractive Errors

Intervention

Device:
• Purevision Lenses with ReNu Multiplus
Purevision lenses using ReNu Multiplus lens solution for 28 days
• Purevision Lenses with Optifree RepleniSH
Purevision lenses using Optifree RepleniSH lens solution for 28 days

Locations

Country	Name	City	State
Canada	University of Waterloo	Waterloo	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantify the ocular response to acute and chronic lens wear using slit lamp examination, tear assay and corneal sensitivity.		5 months