Short-Term Evaluation of Corneal Staining With Balafilcon A Lenses and Two Multi-Purpose Solutions

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2010-11-30

Brief Summary

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An investigational multi-purpose solution (MPS)was clinically evaluated against Biotrue MPS at specific time points over the course of four days. The study was conducted with PureVision lenses.

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Detailed Description

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Conditions

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Corneal Staining

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Biotrue MPS

Group Type ACTIVE_COMPARATOR

Biotrue MPS

Intervention Type DEVICE

Multi-purpose contact lens care solution

Investigational MPS

Group Type EXPERIMENTAL

Investigational MPS

Intervention Type DEVICE

Multi-purpose contact lens care solution

Interventions

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Biotrue MPS

Multi-purpose contact lens care solution

Intervention Type DEVICE

Investigational MPS

Multi-purpose contact lens care solution

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* were at least 18 years old;
* were experienced contact lens wearers;
* were correctable to at least 20/40 or better in both eyes with contact lenses;
* were in good general health, with healthy eyes (other than requiring vision correction);
* had not worn lenses for at least 12 hours before each baseline visit;
* had a corneal staining score no greater than Grade 1 in either eye at time of enrollment;
* had previously used an MPS or hydrogen peroxide solution successfully.

Exclusion Criteria

* had a confirmed diagnosis of Sjögren's syndrome or other condition that results in a chronic and/or pathologic dry eye condition;
* required concurrent ocular medication or have used ocular medication within 24 hours of entering the study;
* had a known sensitivity or intolerance to any MPS, study products or ingredient(s);
* were currently participating in any other clinical study;
* had a condition or are in a situation that, in the investigator's opinion, may put them at significant risk, confound the study results, or interfere significantly with their participation in the study.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes