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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03169153
Other study ID # CLL541-P001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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