Comparison of Lotrafilcon B Lenses With Different Packaging Solutions

Not Applicable

Completed

Conditions: Refractive Error

Interventions: Device: Lotrafilcon B contact lenses with EOBO-41
Device: Lotrafilcon B contact lenses
Device: Hydrogen peroxide-based lens care solution
Device: Saline solution for rinsing contact lenses
Device: Saline solution for rinsing contact lens case

Registration Number: NCT02699684

Lead Sponsor: Alcon Research

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 82

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
AOHG, then AOA	Lotrafilcon B contact lenses	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.
AOHG, then AOA	Hydrogen peroxide-based lens care solution	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.
AOHG, then AOA	Saline solution for rinsing contact lens case	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.
AOHG, then AOA	Lotrafilcon B contact lenses with EOBO-41	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.
AOA, then AOHG	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.
AOA, then AOHG	Lotrafilcon B contact lenses	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.
AOHG, then AOA	Saline solution for rinsing contact lenses	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.
AOA, then AOHG	Lotrafilcon B contact lenses with EOBO-41	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.
AOA, then AOHG	Saline solution for rinsing contact lens case	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.
AOA, then AOHG	Saline solution for rinsing contact lenses	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects Satisfying the "no Re-fit" Criteria in Both Eyes	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.

Secondary Outcome Measures

Name	Time	Method
Change From Insertion in Minimum Protected Area (MPA)	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.
Mean Ex Vivo Total Cholesterol Uptake After 30 Days of Wear	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.