Product Performance of a Toric Contact Lens

Not Applicable

Completed

• Conditions: Myopia; Astigmatism
• Interventions: Device: SofLens DD Toric; Device: Ciba Vision Focus Dailies Toric Contact Lens

• Registration Number: NCT00658996
• Lead Sponsor: Bausch & Lomb Incorporated

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-04-12
• Study First Submitted QC: 2008-04-15
• Study First Posted: 2008-04-16
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Results First Submitted: 2010-12-14
• Results First Submitted QC: 2011-01-20
• Results First Posted: 2011-02-16
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-07
• Last Update Posted: 2011-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
SofLens DD Toric	SofLens DD Toric	Bausch \& Lomb SofLens Daily Disposable Toric Contact Lens
Ciba Vision Toric Lens	Ciba Vision Focus Dailies Toric Contact Lens	Ciba Vision Focus Dailies Toric Contact Lens

Primary Outcome Measures

Name	Time	Method
Symptoms and Complaints	Over-all follow-up visits for 2 week period	1-100 Scale for each eye. Zero represented the least favorable rating and 100 represented the most favorable.
Contact Lens High Contrast Visual Acuity	Over-all follow-up visits, 2 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Slit Lamp Findings	Over-all follow-up visits, 2 weeks	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

Trial Locations

Locations (1)

Laser Focus Sdn Bhd, Vision Correction Centre; 🇲🇾 Johor Bahru, Malaysia