Safety and Efficacy of a Bausch & Lomb Multipurpose Solution When Compared to Ciba Vision Aquify Multipurpose Solution

Bausch & Lomb Incorporated541 enrolled

Overview

To the safety and efficacy of a Bausch \& Lomb Multipurpose Solution when compared to Ciba vision Aquify Multipurpose solution

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

541

Conditions

Contact Lens Solutions

Interventions

Bausch & Lomb Multipurpose Solution - Rub CareDEVICE

Daily care for contact lenses - rub care regimen

Bausch & Lomb Multipurpose Solution - No Rub CareDEVICE

Daily care for contact lenses - no rub care regimen

Ciba Vision Aquify Multipurpose SolutionDEVICE

daily care for contact lenses

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * subject is a habitual wearer of a silicone hydrogel or group IV contact lens * VA correctable to 0.3 LogMar or better (driving vision) * Clear central cornea * Subject uses a lens care system on a regular basis Exclusion Criteria: * Systemic disease affecting ocular health * Using systemic or topical medications * wear monovision, multifocal or toric contact lenses * Any grade 2 or greater slit lamp findings

Locations (1)

Place Eye Care

Le Roy, New York, United States

Outcomes

Primary Outcomes

Slit-lamp Findings > Grade 2

eyes with any slit lamp findings greater than Grade 2 at any visit. Slit lamp findings for each eye will be graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). Epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, superior tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates will be assessed.

Time frame: Over 4 visits for 3 month period

Subjective Responses to Comfort Related Symptoms/Complaints

Subject symptoms/complaints will be assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints.

Time frame: Over 4 visits for the 3 month period

Contact Lens Deposits

Lens deposits assessed at each follow-up visit. Degree of deposits assessed as none, light, medium, or heavy.

Time frame: At each visit for 3 months

Data from ClinicalTrials.gov

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