NCT00639379

Comparison of Two Toric Contact Lenses on Current Toric Wearers

A Multi-Center, Subject Masked, Randomized, Two Week Crossover Design, Investigation of the Acuvue Cypress Toric Silicone Hydrogel Lens Compared to the Bausch & Lomb SofLens66® Toric Hydrophilic Lens

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: Johnson & Johnson Vision Care, Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate and compare the clinical performance of two toric contact lenses amongst 110 subjects, 2-week, single masked (subject), daily wear, randomized, bilateral, crossover study; 4 weeks duration. Hypotheses include equal or better performance of the test lens over the control lenses for comfort, vision, and toric fit characteristics as well as corneal integrity

Detailed description

Up to 7 sites in the US will participate. Each investigator will have both test and control lens types. There will be a maximum of 6 scheduled visits: Visit 1: Habitual lens evaluation / Baseline / Trial fitting Visit 2: Dispensing (to be combined with Visit 1 where possible), Visit 3: Questionnaire only (no exam) 7 days (±2) after dispensing, Visit 4: 2 week follow-up 14 days (±3) after dispensing, and dispense second lens type, Visit 5: Questionnaire only (no exam) 7 days (±2) after 2nd lens dispense, Visit 6: 2 week follow-up 14 days (±3) after 2nd lens dispense

Conditions

• Ametropia

Interventions

Type	Name	Description
DEVICE	senofilcon A toric	silicone hydrogel toric lens, 2 wk replacement, daily wear
DEVICE	alphafilcon A toric	hydrogel toric lens, 2 wk replacement, daily wear

Timeline

• Start date: 2008-02-01
• Primary completion: 2008-06-01
• Completion: 2008-06-01
• First posted: 2008-03-20
• Last updated: 2015-05-21
• Results posted: 2010-07-19

Locations

7 sites across 1 country: United States