Product Performance of a Toric Contact Lens

A Study to Evaluate the Product Performance of a Prism-Ballasted Toric Contact Lens When Worn by Currently Adapted Soft Contact Lens Wearers.

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

Study Overview

• Status: Completed
• Conditions: Astigmatism; Myopia
• Intervention / Treatment: Device: SofLens DD Toric; Device: Ciba Vision Focus Dailies Toric Contact Lens

• Study Type: Interventional
• Enrollment (Actual): 220
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Johor Bahru, Malaysia, 80400
    • Laser Focus Sdn Bhd, Vision Correction Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SofLens DD Toric; Bausch & Lomb SofLens Daily Disposable Toric Contact Lens	Device: SofLens DD Toric; daily disposable wear contact lens for 2 weeks
Active Comparator: Ciba Vision Toric Lens; Ciba Vision Focus Dailies Toric Contact Lens	Device: Ciba Vision Focus Dailies Toric Contact Lens; daily disposable wear contact lens for 2 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptoms and Complaints	1-100 Scale for each eye. Zero represented the least favorable rating and 100 represented the most favorable.	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.	Over-all follow-up visits, 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Over-all follow-up visits, 2 weeks

Collaborators and Investigators

• Sponsor: Bausch & Lomb Incorporated
• Investigators: Study Director: Gerard Cairns, PhD,MCOptom, Bausch & Lomb Incorporated; Principal Investigator: Benny Chian, MCOptom,DO, Laser Focus Sdn Bhd, Vision Correction Centre

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): June 1, 2008
• Study Completion (Actual): June 1, 2008

Study Registration Dates

• First Submitted: April 12, 2008
• First Submitted That Met QC Criteria: April 15, 2008
• First Posted (Estimate): April 16, 2008

Study Record Updates

• Last Update Posted (Estimate): December 12, 2011
• Last Update Submitted That Met QC Criteria: December 7, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism
• Other Study ID Numbers: 559