Ocular Responses to Short and Long-term Lens Wear

NCT ID: NCT00722891

Last Updated: 2019-11-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2009-09-30

Brief 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.

Conditions

Ametropia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Purevision Lens with ReNu

Purevision Lenses with ReNu Multiplus Solution

Group Type: ACTIVE_COMPARATOR

Purevision Lenses with ReNu Multiplus

Intervention Type: DEVICE

Purevision lenses using ReNu Multiplus lens solution for 28 days

Purevision Lenses with RepleniSH

Purevision Lenses with Optifree RepleniSH Solution

Group Type: ACTIVE_COMPARATOR

Purevision Lenses with Optifree RepleniSH

Intervention Type: DEVICE

Purevision lenses using Optifree RepleniSH lens solution for 28 days

Interventions

Purevision Lenses with ReNu Multiplus

Purevision lenses using ReNu Multiplus lens solution for 28 days

Intervention Type: DEVICE

Purevision Lenses with Optifree RepleniSH

Purevision lenses using Optifree RepleniSH lens solution for 28 days

Intervention Type: DEVICE

Other Intervention Names

Balafilcon A; Balafilcon A

Eligibility Criteria

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;

• Minimum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Trefford Simpson, DipOptom,MSc,PhD

Role: PRINCIPAL_INVESTIGATOR

University of Waterloo

Locations

University of Waterloo

Waterloo, Ontario, Canada

Countries

Canada

Other Identifiers

P/289/07/B

Identifier Type: -

Identifier Source: org_study_id