Evaluation of Corneal Staining With Various Contact Lens/Solution Combinations

Andrasko, Gary, OD, LLC

Status: Unknown

Conditions: Corneal Epithelial Disruption; Corneal Staining

Treatments: Device: Marketed contact lens care products

Study type: Interventional

Funder types: Industry

Identifiers

NCT00381446

MS005

Details and patient eligibility

About

The purpose of this study is to quantify the amount of corneal staining observed with various marketed contact lens/multipurpose solution combinations. The hypothesis is that there are measurable differences in the amount of corneal staining between the various combinations.

Full description

A series of clinical studies is being conducted at one research site using a double-masked, randomized cross-over design. Each study consists of asymptomatic daily wear soft contact lens wearers observed at baseline and at two and four hours post lens insertion. Corneal staining is being assessed using sodium fluorescein, a cobalt filter and a yellow filter. Subjective comfort assessments are obtained at each visit.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• currently wearing soft contact lenses daily wear for at least 2 weeks prior to study
• correct visual acuity of 20/30 or better each eye

Exclusion criteria

• history of hypersensitivity to any components of solution being tested
• any ocular condition prohibiting contact lens wear
• excessive baseline staining as defined in protocol
• use of topical or OTC ocular medications during the study
• seasonal allergies with significant effect on contact lens wear

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind