Back to resultsComparison of Lotrafilcon B Lenses With Different Packaging Solutions
Primary Purpose
Refractive Error
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lotrafilcon B contact lenses with EOBO-41
Lotrafilcon B contact lenses
Hydrogen peroxide-based lens care solution
Saline solution for rinsing contact lenses
Saline solution for rinsing contact lens case
Sponsored by
About this trial
This is an interventional other trial for Refractive Error
Eligibility Criteria
Inclusion Criteria:
- Must sign Informed Consent Document;
- Manifest cylinder less than or equal to 0.75 Diopter (D) in each eye;
- Successful current wearer (during the past 2 months for a minimum of 5 days per week and 8 hours per day) of AOA contact lenses within the protocol-specified power range;
- Willing to answer text messages on a daily basis during the study;
- Willing to discontinue artificial tears and rewetting drops on the days of study visits;
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
- Habitual lens wear in an extended wear modality (routinely sleeping in lenses overnight for 1 night per week);
- 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;
- Monocular (only 1 eye with functional vision) or fit with only 1 lens;
- Pregnant or lactating;
- Participation in any clinical study within 30 days of Visit 1;
- Other protocol-specified exclusion criteria may apply.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
AOHG, then AOA
AOA, then AOHG
Arm Description
Lotrafilcon B contact lenses with EOBO-41 worn first, followed by lotrafilcon B contact lenses worn second. Both products worn bilaterally (in both eyes) for 30 days and removed nightly for care using a hydrogen peroxide-based lens care solution.
Lotrafilcon B contact lenses worn first, followed by lotrafilcon B contact lenses with EOBO-41 worn second. Both products worn bilaterally for 30 days and removed nightly for care using a hydrogen peroxide-based lens care solution.
Outcomes
Primary Outcome Measures
Percentage of Subjects Satisfying the "no Re-fit" Criteria in Both Eyes
Overall lens fit was graded by the Investigator on a 5-point scale: -2 (unacceptably tight); -1 (acceptably tight); 0 (optimal fit); +1 (acceptable loose); +2 (unacceptable loose). 'No re-fit' criteria was satisfied if an acceptable or optimal overall lens fit, that was also within one grade of the habitual lens fit value, was achieved.
Secondary Outcome Measures
Mean Ex Vivo Total Cholesterol Uptake After 30 Days of Wear
The contact lens was removed from the eye. Cholesterol deposits were extracted and measured in micrograms (μg) per lens. Lower deposits indicate increased lens performance. Only one eye (right eye) contributed to the analysis.
Change From Insertion in Minimum Protected Area (MPA)
MPA (the minimum area of the contact lens surface (expressed in %) protected by the tear film between two natural blinks) was assessed by the Investigator during the interblink period using the Tearscope® lighting system. Higher values indicate a more stable tear film in front of the lens. This Outcome Measure was pre-specified for AOHG only. Both eyes contributed to the analysis.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02699684
Brief Title
Comparison of Lotrafilcon B Lenses With Different Packaging Solutions
Official Title
One Month Clinical Comparison of Two Lotrafilcon B Spherical Lenses With Different Packaging Solutions
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
May 12, 2016 (Actual)
Primary Completion Date
October 20, 2016 (Actual)
Study Completion Date
October 20, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate AIR OPTIX® plus HYDRAGLYDE® (AOHG) contact lenses compared to AIR OPTIX® AQUA (AOA) contact lenses in overall lens fit.
Detailed Description
Subjects must not wear any contact lenses prior to the visit on Day 1 (Insertion) for Period 1 or Day 1 (Insertion) for Period 2.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Error
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
82 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AOHG, then AOA
Arm Type
Other
Arm Description
Lotrafilcon B contact lenses with EOBO-41 worn first, followed by lotrafilcon B contact lenses worn second. Both products worn bilaterally (in both eyes) for 30 days and removed nightly for care using a hydrogen peroxide-based lens care solution.
Arm Title
AOA, then AOHG
Arm Type
Other
Arm Description
Lotrafilcon B contact lenses worn first, followed by lotrafilcon B contact lenses with EOBO-41 worn second. Both products worn bilaterally for 30 days and removed nightly for care using a hydrogen peroxide-based lens care solution.
Intervention Type
Device
Intervention Name(s)
Lotrafilcon B contact lenses with EOBO-41
Other Intervention Name(s)
AIR OPTIX® plus HYDRAGLYDE®, AOHG
Intervention Description
Lotrafilcon B contact lenses packaged with copolymer 845 and EOBO-41
Intervention Type
Device
Intervention Name(s)
Lotrafilcon B contact lenses
Other Intervention Name(s)
AIR OPTIX® AQUA, AOA
Intervention Description
Lotrafilcon B contact lenses packaged with copolymer 845
Intervention Type
Device
Intervention Name(s)
Hydrogen peroxide-based lens care solution
Other Intervention Name(s)
AOSEPT® PLUS, CLEAR CARE® PLUS
Intervention Description
Commercially-available hydrogen peroxide-based lens care solution for cleaning, disinfecting, and storing silicone hydrogel soft contact lenses
Intervention Type
Device
Intervention Name(s)
Saline solution for rinsing contact lenses
Other Intervention Name(s)
Minims®
Intervention Description
Commercially-available saline solution used as needed
Intervention Type
Device
Intervention Name(s)
Saline solution for rinsing contact lens case
Other Intervention Name(s)
LENS PLUS® OCUPURE™
Intervention Description
Commercially-available solution used as needed
Primary Outcome Measure Information:
Title
Percentage of Subjects Satisfying the "no Re-fit" Criteria in Both Eyes
Description
Overall lens fit was graded by the Investigator on a 5-point scale: -2 (unacceptably tight); -1 (acceptably tight); 0 (optimal fit); +1 (acceptable loose); +2 (unacceptable loose). 'No re-fit' criteria was satisfied if an acceptable or optimal overall lens fit, that was also within one grade of the habitual lens fit value, was achieved.
Time Frame
Day 30, each product
Secondary Outcome Measure Information:
Title
Mean Ex Vivo Total Cholesterol Uptake After 30 Days of Wear
Description
The contact lens was removed from the eye. Cholesterol deposits were extracted and measured in micrograms (μg) per lens. Lower deposits indicate increased lens performance. Only one eye (right eye) contributed to the analysis.
Time Frame
Day 30, each product
Title
Change From Insertion in Minimum Protected Area (MPA)
Description
MPA (the minimum area of the contact lens surface (expressed in %) protected by the tear film between two natural blinks) was assessed by the Investigator during the interblink period using the Tearscope® lighting system. Higher values indicate a more stable tear film in front of the lens. This Outcome Measure was pre-specified for AOHG only. Both eyes contributed to the analysis.
Time Frame
Hour 0 (Lens Insertion) to Hour 12 on Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Must sign Informed Consent Document;
Manifest cylinder less than or equal to 0.75 Diopter (D) in each eye;
Successful current wearer (during the past 2 months for a minimum of 5 days per week and 8 hours per day) of AOA contact lenses within the protocol-specified power range;
Willing to answer text messages on a daily basis during the study;
Willing to discontinue artificial tears and rewetting drops on the days of study visits;
Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
Habitual lens wear in an extended wear modality (routinely sleeping in lenses overnight for 1 night per week);
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;
Monocular (only 1 eye with functional vision) or fit with only 1 lens;
Pregnant or lactating;
Participation in any clinical study within 30 days of Visit 1;
Other protocol-specified exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Manager, EMEA
Organizational Affiliation
Alcon, A Novartis Division
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Comparison of Lotrafilcon B Lenses With Different Packaging Solutions
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