Clinical Comparison of Silicone Hydrogel Monthly Lenses

NCT03169153 | Completed Results

• 1 other identifier: CLL541-P001
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Refractive Error

Keywords

contact lenses; lipids; deposits

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Lotrafilcon B, then senofilcon C

OTHER

Lotrafilcon B contact lenses worn first, followed by senofilcon C contact lenses, as randomized. Each product worn bilaterally (in both eyes) for a total duration of 30 (+ 3) days under a daily wear modality for the specific study period. The lenses will be removed every night and cared for with the subject's habitual lens care solution.

Device: Lotrafilcon B contact lenses; Device: Senofilcon C contact lenses

Senofilcon C, then lotrafilcon B

OTHER

Senofilcon C contact lenses worn first, followed by lotrafilcon B contact lenses, as randomized. Each product worn bilaterally (in both eyes) for a total duration of 30 (+ 3) days under a daily wear modality for the specific study period. The lenses will be removed every night and cared for with the subject's habitual lens care solution.

Device: Lotrafilcon B contact lenses; Device: Senofilcon C contact lenses

Interventions

Lotrafilcon B contact lenses DEVICE

Silicone hydrogel contact lenses used as per their Conformité Européenne (CE) marking

Also known as: AIR OPTIX® plus HydraGlyde

Lotrafilcon B, then senofilcon C; Senofilcon C, then lotrafilcon B

Senofilcon C contact lenses DEVICE

Silicone hydrogel contact lenses used as per their Conformité Européenne (CE) marking

Also known as: ACUVUE® VITA®

Lotrafilcon B, then senofilcon C; Senofilcon C, then lotrafilcon B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (1)

Alcon Investigative Site

London, SW1E 6AU, United Kingdom

Location

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

• Title: CDMA Project Lead
• Organization: Alcon Research

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Clinical Manager, Medical Clinical Trial Services

  Alcon Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2017
• First Posted: May 30, 2017
• Study Start: September 22, 2017
• Primary Completion: July 19, 2018
• Study Completion: July 19, 2018
• Last Updated: July 25, 2019
• Results First Posted: July 25, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)