Clinical Comparison of Silicone Hydrogel Monthly Lenses

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03169153
• Collaborator: (none)
• Enrollment: 114
• Location: 1
• Arms: 2
• Actual Duration (Months): 9.9
• Patients Per Site Per Month: 11.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Refractive Error	Device: Lotrafilcon B contact lenses; Device: Senofilcon C contact lenses	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 114 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: One-month Clinical Comparison of Silicone Hydrogel Monthly Lenses in High Lipid Depositors
• Actual Study Start Date: Sep 22, 2017
• Actual Primary Completion Date: Jul 19, 2018
• Actual Study Completion Date: Jul 19, 2018

Arms and Interventions

Arm	Intervention/Treatment
Other: Lotrafilcon B, then senofilcon C 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.	Device: Lotrafilcon B contact lenses; Silicone hydrogel contact lenses used as per their Conformité Européenne (CE) marking; Other Names: AIR OPTIX® plus HydraGlyde ; Device: Senofilcon C contact lenses; Silicone hydrogel contact lenses used as per their Conformité Européenne (CE) marking; Other Names: ACUVUE® VITA®
Other: Senofilcon C, then lotrafilcon B 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.	Device: Lotrafilcon B contact lenses; Silicone hydrogel contact lenses used as per their Conformité Européenne (CE) marking; Other Names: AIR OPTIX® plus HydraGlyde ; Device: Senofilcon C contact lenses; Silicone hydrogel contact lenses used as per their Conformité Européenne (CE) marking; Other Names: ACUVUE® VITA®

Outcome Measures

Primary Outcome Measures

1. Mean Ex-vivo Total Lipid Uptake (Total of Surface and Bulk Uptake) Per Lens [Day 30 after 10 hours of wear, each product]

   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.

Eligibility Criteria

Criteria

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

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alcon Investigative Site	London		United Kingdom	SW1E 6AU

Sponsors and Collaborators

• Alcon Research

Investigators

• Study Director: Clinical Manager, Medical Clinical Trial Services, Alcon Research

Study Documents (Full-Text)

• Study Protocol - Dec 7, 2017
• Statistical Analysis Plan - Jul 3, 2018

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT03169153
• Other Study ID Numbers: CLL541-P001
• First Posted: May 30, 2017
• Last Update Posted: Jul 25, 2019
• Last Verified: May 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Alcon Research: contact lenses; lipids; deposits
• Additional relevant MeSH terms: Refractive Errors

Study Results

Participant Flow

Recruitment Details	Subjects were recruited from 1 study center located in the United Kingdom.
Pre-assignment Detail	Of the 114 enrolled, 29 subjects were exited prior to randomization. An additional 4 subjects discontinued after randomization but prior to exposure. This reporting group includes all randomized and exposed subjects (81).

Arm/Group Title	AOHG Then VITA	VITA Then AOHG
Arm/Group 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 were 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 for a total duration of 30 (+ 3) days under a daily wear modality for the specific study period. The lenses were removed every night and cared for with the subject's habitual lens care solution.
Period Title: Period 1, First 30 Days of Wear
STARTED	42	39
COMPLETED	39	35
NOT COMPLETED	3	4
Period Title: Period 1, First 30 Days of Wear
STARTED	39	34
COMPLETED	37	32
NOT COMPLETED	2	2

Baseline Characteristics

Arm/Group Title	Overall
Arm/Group Description	Lotrafilcon B and senofilcon C contact lenses worn during Period 1 and Period 2 in a crossover assignment.
Overall Participants	81
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	32.3 (9.8)
Sex: Female, Male (Count of Participants)
Female	60 74.1%
Male	21 25.9%
Race and Ethnicity Not Collected (Count of Participants)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Full Analysis Set with non-missing response

Arm/Group Title	AOHG	VITA
Arm/Group Description	Lotrafilcon B contact lenses worn bilaterally for 30 (+ 3) days under a daily wear modality. The lenses were removed every night and cared for with the subject's habitual lens care solution.	Senofilcon C contact lenses worn bilaterally for 30 (+ 3) days under a daily wear modality. The lenses were removed every night and cared for with the subject's habitual lens care solution.
Measure Participants	59	56
Mean (Standard Deviation) [micrograms (μg)]	78.1398 (70.7923)	307.6800 (303.9299)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	AOHG, VITA
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Mixed effects repeated measures
	Comments

Adverse Events

Time Frame	Dispense through study completion, an average of 2.5 months
Adverse Event Reporting Description	An adverse event (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 study lenses. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
Arm/Group Title	AOHG		VITA
Arm/Group Description	All subjects exposed to lotrafilcon B contact lenses		All subjects exposed to senofilcon C contact lenses
All Cause Mortality
	AOHG		VITA
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/76 (0%)		0/78 (0%)
Serious Adverse Events
	AOHG		VITA
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/76 (0%)		0/78 (0%)
Other (Not Including Serious) Adverse Events
	AOHG		VITA
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/76 (0%)		0/78 (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.