Lotrafilcon B contact lenses with EOBO-41
DeviceLotrafilcon B contact lenses packaged with copolymer 845 and EOBO-41
Other names: AIR OPTIX® plus HYDRAGLYDE®, AOHG
NCT Number: NCT02699684
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Lotrafilcon B contact lenses packaged with copolymer 845 and EOBO-41
Other names: AIR OPTIX® plus HYDRAGLYDE®, AOHG
Lotrafilcon B contact lenses packaged with copolymer 845
Other names: AIR OPTIX® AQUA, AOA
Commercially-available hydrogen peroxide-based lens care solution for cleaning, disinfecting, and storing silicone hydrogel soft contact lenses
Other names: AOSEPT® PLUS, CLEAR CARE® PLUS
Commercially-available saline solution used as needed
Other names: Minims®
Commercially-available solution used as needed
Other names: LENS PLUS® OCUPURE™
Time frame: Day 30, each product
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
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: Hour 0 (Lens Insertion) to Hour 12 on Day 1
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.
Alcon Research
Industry
One Month Clinical Comparison of Two Lotrafilcon B Spherical Lenses With Different Packaging Solutions
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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