Comparison of Lotrafilcon B Lenses With Different Packaging Solutions

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02699684
• Collaborator: (none)
• Enrollment: 82
• Arms: 2
• Actual Duration (Months): 5.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Refractive Error	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	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 82 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Other
• Official Title: One Month Clinical Comparison of Two Lotrafilcon B Spherical Lenses With Different Packaging Solutions
• Actual Study Start Date: May 12, 2016
• Actual Primary Completion Date: Oct 20, 2016
• Actual Study Completion Date: Oct 20, 2016

Arms and Interventions

Arm	Intervention/Treatment
Other: AOHG, then AOA 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.	Device: Lotrafilcon B contact lenses with EOBO-41; Lotrafilcon B contact lenses packaged with copolymer 845 and EOBO-41; Other Names: AIR OPTIX® plus HYDRAGLYDE® AOHG ; Device: Lotrafilcon B contact lenses; Lotrafilcon B contact lenses packaged with copolymer 845; Other Names: AIR OPTIX® AQUA AOA ; Device: Hydrogen peroxide-based lens care solution; 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 ; Device: Saline solution for rinsing contact lenses; Commercially-available saline solution used as needed; Other Names: Minims® ; Device: Saline solution for rinsing contact lens case; Commercially-available solution used as needed; Other Names: LENS PLUS® OCUPURE™
Other: AOA, then AOHG 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.	Device: Lotrafilcon B contact lenses with EOBO-41; Lotrafilcon B contact lenses packaged with copolymer 845 and EOBO-41; Other Names: AIR OPTIX® plus HYDRAGLYDE® AOHG ; Device: Lotrafilcon B contact lenses; Lotrafilcon B contact lenses packaged with copolymer 845; Other Names: AIR OPTIX® AQUA AOA ; Device: Hydrogen peroxide-based lens care solution; 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 ; Device: Saline solution for rinsing contact lenses; Commercially-available saline solution used as needed; Other Names: Minims® ; Device: Saline solution for rinsing contact lens case; Commercially-available solution used as needed; Other Names: LENS PLUS® OCUPURE™

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Alcon Research

Investigators

• Study Director: Clinical Trial Manager, EMEA, Alcon, A Novartis Division

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT02699684
• Other Study ID Numbers: CLE270-P001
• First Posted: Mar 4, 2016
• Last Update Posted: Jul 2, 2018
• Last Verified: Aug 1, 2017

• Additional relevant MeSH terms: Refractive Errors; Hydrogen Peroxide; Pharmaceutical Solutions

Study Results

Participant Flow

Recruitment Details	Subjects were recruited from 1 study center located in the United Kingdom (UK).
Pre-assignment Detail	Of the 82 enrolled, 6 subjects were exited as screen failures prior to randomization. One subject withdrew consent after randomization, but before exposure to product. This reporting group includes all randomized and exposed subjects (75).

Arm/Group Title	AOHG, Then AOA	AOA, Then AOHG
Arm/Group 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.
Period Title: Period 1, First 30 Days of Wear
STARTED	37	38
COMPLETED	37	38
NOT COMPLETED	0	0
Period Title: Period 1, First 30 Days of Wear
STARTED	37	38
COMPLETED	36	38
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	Overall
Arm/Group Description	Lotrafilcon B contact lenses with EOBO-41 and lotrafilcon B contact lenses worn bilaterally during Period 1 and Period 2 in a crossover assignment, as randomized.
Overall Participants	75
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	35.7 (10.30)
Sex: Female, Male (Count of Participants)
Female	51 68%
Male	24 32%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Full Analysis Set. Number Analyzed is the number of subjects with non-missing response.

Arm/Group Title	AOHG Contact Lenses	AOA Contact Lenses
Arm/Group Description	Lotrafilcon B contact lenses with EOBO-41 worn bilaterally for 30 days in Period 1 or 2, as randomized	Lotrafilcon B contact lenses worn bilaterally for 30 days in Period 1 or 2, as randomized
Measure Participants	75	74
Number [percentage of subjects]	93.3	94.6

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Full Analysis Set. Only the right (OD) lenses were collected from a subset of subjects.

Arm/Group Title	AOHG Contact Lenses	AOA Contact Lenses
Arm/Group Description	Lotrafilcon B contact lenses with EOBO-41 worn bilaterally for 30 days in Period 1 or 2, as randomized	Lotrafilcon B contact lenses worn bilaterally for 30 days in Period 1 or 2, as randomized
Measure Participants	32	32
Mean (Standard Deviation) [μg]	0.44 (0.231)	0.27 (0.173)

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Full Analysis Set. Number Analyzed is the number of eyes with non-missing response.

Arm/Group Title	AOHG Contact Lenses
Arm/Group Description	Lotrafilcon B contact lenses with EOBO-41 worn bilaterally for 30 days in Period 1 or 2, as randomized
Measure Participants	45
Measure Eyes	90
Insertion (Hour 0)	86.839 (24.775)
Change from Insertion (Hour 12 - Hour 0)	4.396 (23.060)

Adverse Events

Time Frame	Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 74 days). AEs are reported as pre-treatment and treatment-emergent.
Adverse Event Reporting Description	An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device.
Arm/Group Title	Pretreatment		AOHG Contact Lenses		AOA Contact Lenses
Arm/Group Description	All subjects who consented to participate in the study prior to initiation of study treatment		All subjects exposed to AOHG contact lenses		All subjects exposed to AOA contact lenses
All Cause Mortality
	Pretreatment		AOHG Contact Lenses		AOA Contact Lenses
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/82 (0%)		0/75 (0%)		0/75 (0%)
Serious Adverse Events
	Pretreatment		AOHG Contact Lenses		AOA Contact Lenses
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/82 (0%)		1/75 (1.3%)		0/75 (0%)
Gastrointestinal disorders
Food Poisoning	0/82 (0%)		1/75 (1.3%)		0/75 (0%)
Other (Not Including Serious) Adverse Events
	Pretreatment		AOHG Contact Lenses		AOA Contact Lenses
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/82 (0%)		0/75 (0%)		0/75 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Sponsor reserves the right of prior review of any publication or presentation of information related to the study.