Comparison of Two Marketed Silicone Hydrogel Lenses

Refractive Error Clinical Trial

Official title:

One Month Clinical Comparison of Lotrafilcon B and Samfilcon A

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02495948
• Other study ID #: CLA560-P001
• Status: Completed
• Phase: N/A
• First received: July 9, 2015
• Last updated: October 28, 2015
• Start date: July 2015
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Refractive Error
• Refractive Errors

Intervention

Device:
• Lotrafilcon B contact lenses

• Samfilcon A contact lenses

Locations

Country	Name	City	State
United States	Contact Alcon Call Center for Trial Locations	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean ex-vivo cholesterol deposits after 30 days of wear	The contact lens will be removed from the eye. Cholesterol deposits will be extracted and measured in micrograms per lens.	Day 31	No