Clinical Comparison of Silicone Hydrogel Monthly Lenses

Refractive Error Clinical Trial

Official title:

One-month Clinical Comparison of Silicone Hydrogel Monthly Lenses in High Lipid Depositors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03169153
• Other study ID #: CLL541-P001
• Status: Completed
• Phase: N/A
• Start date: September 22, 2017
• Est. completion date: July 19, 2018

Study information

• Verified date: May 2019
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare AIR OPTIX® plus HydraGlyde (AOHG) contact lenses to ACUVUE® VITA® (VITA) contact lenses for total lipid uptake (total of surface and bulk uptake) after 30 days of wear by high lipid depositors.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: July 19, 2018
• Est. primary completion date: July 19, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Sign Informed Consent;

• Best corrected visual acuity (BCVA) of at least 0.1 logarithm of the minimum angle of resolution (logMAR) in each eye at Visit 1;

• Manifest cylinder less than or equal to 0.75 diopter (D) in each eye at Visit 1;

• Successful current wearer (during the past 2 months for a minimum of 5 days per week and 8 hours per day) of monthly replacement silicone hydrogel lenses within the power range of lens powers available for the screening and study lenses;

• Screening lenses worn 10 hours exhibiting high lipid uptake.

Exclusion Criteria:

• Habitual lens used in an extended wear modality (routinely sleeping in lenses overnight for 1 night per week or more) during the past 2 months;

• Habitually wearing AIR OPTIX AQUA, AIR OPTIX plus HydraGlyde, ACUVUE OASYS®, or ACUVUE VITA as contact lenses during the past 2 months;

• 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 for which contact lens wear could be contraindicated, as determined by the Investigator;

• Abnormal ocular conditions or findings, as specified in the protocol;

• Known pregnancy and lactation.

Related Conditions & MeSH terms

• Refractive Error
• Refractive Errors

Intervention

Device:
• Lotrafilcon B contact lenses
Silicone hydrogel contact lenses used as per their Conformité Européenne (CE) marking
• Senofilcon C contact lenses
Silicone hydrogel contact lenses used as per their Conformité Européenne (CE) marking

Locations

Country	Name	City	State
United Kingdom	Alcon Investigative Site	London

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Ex-vivo Total Lipid Uptake (Total of Surface and Bulk Uptake) Per Lens	Contact lens was removed aseptically from the eye. Total lipid (fatty deposits) uptake, defined as total amount of lipids (surface and bulk) absorbed/adsorbed and extracted, was measured in micrograms. A lower value indicates better results. Only one lens from each subject contributed to the analysis.	Day 30 after 10 hours of wear, each product