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Clinical Comparison of Silicone Hydrogel Monthly Lenses

Primary Purpose

Refractive Error

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Lotrafilcon B contact lenses
Senofilcon C contact lenses
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractive Error focused on measuring contact lenses, lipids, deposits

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Alcon Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Lotrafilcon B, then senofilcon C

Senofilcon C, then lotrafilcon B

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 25, 2017
Last Updated
May 23, 2019
Sponsor
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT03169153
Brief Title
Clinical Comparison of Silicone Hydrogel Monthly Lenses
Official Title
One-month Clinical Comparison of Silicone Hydrogel Monthly Lenses in High Lipid Depositors
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
September 22, 2017 (Actual)
Primary Completion Date
July 19, 2018 (Actual)
Study Completion Date
July 19, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Error
Keywords
contact lenses, lipids, deposits

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
114 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lotrafilcon B, then senofilcon C
Arm Type
Other
Arm Description
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.
Arm Title
Senofilcon C, then lotrafilcon B
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Lotrafilcon B contact lenses
Other Intervention Name(s)
AIR OPTIX® plus HydraGlyde
Intervention Description
Silicone hydrogel contact lenses used as per their Conformité Européenne (CE) marking
Intervention Type
Device
Intervention Name(s)
Senofilcon C contact lenses
Other Intervention Name(s)
ACUVUE® VITA®
Intervention Description
Silicone hydrogel contact lenses used as per their Conformité Européenne (CE) marking
Primary Outcome Measure Information:
Title
Mean Ex-vivo Total Lipid Uptake (Total of Surface and Bulk Uptake) Per Lens
Description
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.
Time Frame
Day 30 after 10 hours of wear, each product

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Manager, Medical Clinical Trial Services
Organizational Affiliation
Alcon Research
Official's Role
Study Director
Facility Information:
Facility Name
Alcon Investigative Site
City
London
ZIP/Postal Code
SW1E 6AU
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Clinical Comparison of Silicone Hydrogel Monthly Lenses

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