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Clinical Comparison of Silicone Hydrogel Monthly Lenses

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ClinicalTrials.gov Identifier: NCT03169153
Recruitment Status : Completed
First Posted : May 30, 2017
Results First Posted : July 25, 2019
Last Update Posted : July 25, 2019
Sponsor:
Information provided by (Responsible Party):
Alcon Research

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.

Condition or disease Intervention/treatment Phase
Refractive Error Device: Lotrafilcon B contact lenses Device: Senofilcon C contact lenses Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: One-month Clinical Comparison of Silicone Hydrogel Monthly Lenses in High Lipid Depositors
Actual Study Start Date : September 22, 2017
Actual Primary Completion Date : July 19, 2018
Actual Study Completion Date : July 19, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Lotrafilcon B, then senofilcon C
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
Silicone hydrogel contact lenses used as per their Conformité Européenne (CE) marking
Other Name: AIR OPTIX® plus HydraGlyde

Device: Senofilcon C contact lenses
Silicone hydrogel contact lenses used as per their Conformité Européenne (CE) marking
Other Name: ACUVUE® VITA®

Senofilcon C, then lotrafilcon B
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
Silicone hydrogel contact lenses used as per their Conformité Européenne (CE) marking
Other Name: AIR OPTIX® plus HydraGlyde

Device: Senofilcon C contact lenses
Silicone hydrogel contact lenses used as per their Conformité Européenne (CE) marking
Other Name: ACUVUE® VITA®




Primary Outcome Measures :
  1. Mean Ex-vivo Total Lipid Uptake (Total of Surface and Bulk Uptake) Per Lens [ Time Frame: Day 30 after 10 hours of wear, each product ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03169153


Locations
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United Kingdom
Alcon Investigative Site
London, United Kingdom, SW1E 6AU
Sponsors and Collaborators
Alcon Research
Investigators
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Study Director: Clinical Manager, Medical Clinical Trial Services Alcon Research
  Study Documents (Full-Text)

Documents provided by Alcon Research:
Study Protocol  [PDF] December 7, 2017
Statistical Analysis Plan  [PDF] July 3, 2018

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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT03169153    
Other Study ID Numbers: CLL541-P001
First Posted: May 30, 2017    Key Record Dates
Results First Posted: July 25, 2019
Last Update Posted: July 25, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Alcon Research:
contact lenses
lipids
deposits
Additional relevant MeSH terms:
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Refractive Errors
Eye Diseases