Product Performance of a Toric Contact Lens

N/ACompletedNCT00658996

Bausch & Lomb Incorporated220 enrolled

Overview

Product performance of a Bausch \& Lomb Toric Contact Lens compared to Ciba Vision Focus Daily Toric Contact Lens

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

220

Conditions

Myopia Astigmatism

Interventions

SofLens DD ToricDEVICE

daily disposable wear contact lens for 2 weeks

Ciba Vision Focus Dailies Toric Contact LensDEVICE

daily disposable wear contact lens for 2 weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subject is an adapted soft contact lens wearer with astigmatism of 0.50 Diopter or greater * Visual acuity (VA) correctable to 0.3 logMar or better (driving vision) * Clear central cornea Exclusion Criteria: * Systemic disease affecting ocular health * Using systemic or topical medications * Wears monovision or multifocal contact lenses * Any grade 2 or greater slit lamp findings * Adapted wearer of Ciba Focus Dailies Toric lens upon study entry

Locations (1)

Laser Focus Sdn Bhd, Vision Correction Centre

Johor Bahru, Malaysia

Outcomes

Primary Outcomes

Symptoms and Complaints

1-100 Scale for each eye. Zero represented the least favorable rating and 100 represented the most favorable.

Time frame: Over-all follow-up visits for 2 week period

Contact Lens High Contrast Visual Acuity

VA measures at each scheduled visit were averaged to obtain an overall measure for each eye. A non-inferiority upper bound of 0.06 (3 letters) were used to assess the difference (Test - Control) in overall logMAR VA.

Time frame: Over-all follow-up visits, 2 weeks

Secondary Outcomes

Slit Lamp Findings

Graded 0-4 where 0=none and 4=severe on measure of epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, superior tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates

Time frame: Over-all follow-up visits, 2 weeks

Data from ClinicalTrials.gov

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