One Month Clinical Comparison of Lotrafilcon B and Samfilcon A
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Alcon Research
- Enrollment
- 168
- Primary Endpoint
- Mean Ex-vivo Cholesterol Deposits After 30 Days of Wear
Study Overview
Brief Summary
The purpose of this study is to evaluate cholesterol sorption by AIR OPTIX® AQUA lenses compared to ULTRA lenses after 30 days of wear.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Sign informed consent document;
- •Vision correctable to 20/40 Snellen (feet) or better in each eye at distance with both study contact lenses;
- •Willing to wear study lenses on a daily basis (minimum 5 days/week, 8 hours/day) and attend all study visits;
- •Successful wear of single-vision spherical, 2-week/ monthly replacement silicone hydrogel contact lenses in both eyes daily wear during the past 2 months for a minimum of 5 days/week, 8 hours/day. (Note: Monovision is included);
- •Other protocol-specified inclusion criteria may apply.
Exclusion Criteria
- •Any anterior segment infection, inflammation, disease or abnormality that contraindicates contact lens wear (within 7 days of enrollment, or current);
- •History of herpetic keratitis, corneal surgery or irregular cornea;
- •Any use of systemic or ocular medications within the past 30 days for which contact lens wear could be contraindicated as determined by the investigator;
- •Monocular (only 1 eye with functional vision) or fit with only one lens;
- •Current or past AIR OPTIX® AQUA or ULTRA lens wearers;
- •Other protocol-specified exclusion criteria may apply.
Arms & Interventions
AOA then ULTRA
Lotrafilcon B contact lenses worn first, followed by samfilcon A contact lenses. Each product worn bilaterally (in both eyes) for a minimum of 5 days/week, 8 hours/day for 30 days in a daily wear modality.
Intervention: Samfilcon A contact lenses (Device)
AOA then ULTRA
Lotrafilcon B contact lenses worn first, followed by samfilcon A contact lenses. Each product worn bilaterally (in both eyes) for a minimum of 5 days/week, 8 hours/day for 30 days in a daily wear modality.
Intervention: Lotrafilcon B contact lenses (Device)
AOA then ULTRA
Lotrafilcon B contact lenses worn first, followed by samfilcon A contact lenses. Each product worn bilaterally (in both eyes) for a minimum of 5 days/week, 8 hours/day for 30 days in a daily wear modality.
Intervention: Hydrogen peroxide solution (Device)
AOA then ULTRA
Lotrafilcon B contact lenses worn first, followed by samfilcon A contact lenses. Each product worn bilaterally (in both eyes) for a minimum of 5 days/week, 8 hours/day for 30 days in a daily wear modality.
Intervention: Saline solution (Device)
ULTRA then AOA
Samfilcon A contact lenses worn first, followed by lotrafilcon B contact lenses. Each product worn bilaterally for a minimum of 5 days/week, 8 hours/day for 30 days in a daily wear modality.
Intervention: Lotrafilcon B contact lenses (Device)
ULTRA then AOA
Samfilcon A contact lenses worn first, followed by lotrafilcon B contact lenses. Each product worn bilaterally for a minimum of 5 days/week, 8 hours/day for 30 days in a daily wear modality.
Intervention: Samfilcon A contact lenses (Device)
ULTRA then AOA
Samfilcon A contact lenses worn first, followed by lotrafilcon B contact lenses. Each product worn bilaterally for a minimum of 5 days/week, 8 hours/day for 30 days in a daily wear modality.
Intervention: Hydrogen peroxide solution (Device)
ULTRA then AOA
Samfilcon A contact lenses worn first, followed by lotrafilcon B contact lenses. Each product worn bilaterally for a minimum of 5 days/week, 8 hours/day for 30 days in a daily wear modality.
Intervention: Saline solution (Device)
Outcomes
Primary Outcomes
Mean Ex-vivo Cholesterol Deposits After 30 Days of Wear
Time Frame: Day 30, each product
The contact lens (right eye) was removed and stored dry and frozen until analysis. Total cholesterol deposits (cholesterol and cholesterol esters) were extracted from the lens and measured in micrograms. Lower deposits indicate increased lens performance. Study originally intended to analyze 36 lenses per arm, but actual number of lenses analyzed was less due to measurement error.
Secondary Outcomes
No secondary outcomes reported