INVERMERE: Lens Wear Schedules and End-of-Day Comfort

• Sponsor: CIBA VISION (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01433549
• Collaborator: University of Waterloo (Other)
• Enrollment: 44
• Location: 1
• Arms: 2
• Duration (Months): 7
• Patients Per Site Per Month: 6.3

Study Details

Study Description

Brief Summary

The purpose of this study was to assess the impact of lens-free (recovery) intervals of varying lengths on end-of-day comfort and tear film changes with daily contact lens wear.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: Lotrafilcon B; Device: Senofilcon A	N/A

Detailed Description

This study was conducted in a cross-over design with two phases. Each phase consisted of four cycles approximately 12 hours in length. During each cycle, contact lenses were worn for 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes. A new pair of contact lenses was dispensed for each 2-hour interval of lens wear. A 12-hour lens-free wear period preceded each phase.

Study Design

• Study Type: Interventional
• Actual Enrollment: 44 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Supportive Care
• Official Title: Effect of Recovery Periods on Ocular Comfort During Daily Lens Wear
• Study Start Date: Aug 1, 2011
• Actual Primary Completion Date: Mar 1, 2012
• Actual Study Completion Date: Mar 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Other: Lotrafilcon B / Senofilcon A Lotrafilcon B worn first, with senofilcon A worn second, as randomized. Each product was worn bilaterally in 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes, over the course of a 12-hour day, for a total of 4 cycles (days).	Device: Lotrafilcon B; Commercially marketed, silicone hydrogel, single-vision contact lens FDA-approved for daily wear and extended (overnight) wear up to 6 nights.; Other Names: AIR OPTIX® AQUA ; Device: Senofilcon A; Commercially marketed, silicone hydrogel, single-vision contact lens FDA-approved for daily wear and extended (overnight) wear up to 6 nights.; Other Names: ACUVUE® OASYS®
Other: Senofilcon A / Lotrafilcon B Senofilcon A worn first, with lotrafilcon B worn second, as randomized. Each product was worn bilaterally in 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes, over the course of a 12-hour day, for a total of 4 cycles (days).	Device: Lotrafilcon B; Commercially marketed, silicone hydrogel, single-vision contact lens FDA-approved for daily wear and extended (overnight) wear up to 6 nights.; Other Names: AIR OPTIX® AQUA ; Device: Senofilcon A; Commercially marketed, silicone hydrogel, single-vision contact lens FDA-approved for daily wear and extended (overnight) wear up to 6 nights.; Other Names: ACUVUE® OASYS®

Outcome Measures

Primary Outcome Measures

1. Mean End-of-Day Comfort [Hour 12]

   As assessed by the participant using a visual analog scale ranging from 0 (extremely uncomfortable) to 100 (very comfortable and fresh) at the end of each 12-hour (approximate) cycle. During each cycle, contact lenses were worn for 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes. A new pair of contact lenses was dispensed for each 2-hour interval of lens wear.

Secondary Outcome Measures

1. Mean Non-Invasive Tear Film Break-Up Time (NITBUT) [Hour 12]

   As assessed by the investigator using a corneal topographer. NITBUT was assessed at the end of each 12-hour (approximate) cycle. During each cycle, contact lenses were worn for 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes. A new pair of contact lenses was dispensed for each 2-hour interval of lens wear. A longer tear film break-up time indicates a more stable tear film and may lead to a more comfortable lens-wearing experience.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 17 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Is at least 17 years of age and has full legal capacity to volunteer.

• Is willing and able to follow instructions and maintain the appointment schedule.

• Has had an ocular examination in the last two years.

• Is an adapted soft contact lens wearer.

• Experiences a decrease in ocular comfort through a lens-wearing day.

• Has a current pair of spectacles.

• Has a distance contact lens prescription of +6.00 diopters to -10.00 diopters and an acceptable fit with the study lenses.

• Has astigmatism less than or equal to -1.00 DC.

• Achieves visual acuity of 6/9 or better with the study lenses and with habitual spectacles.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Has any ocular disease.

• Has a systemic condition that may affect a study outcome variable.

• Is using any systemic or topical medications that may affect ocular health.

• Has known sensitivity to the diagnostic pharmaceuticals to be used in the study.

• Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Waterloo Centre for Contact Lens Research	Waterloo	Ontario	Canada	N2L 3G1

Sponsors and Collaborators

• CIBA VISION
• University of Waterloo

Investigators

• Principal Investigator: Lyndon Jones, PhD FCOptom FAAO, Director, Centre for Contact Lens Research, School of Optometry, University of Waterloo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: CIBA VISION
• ClinicalTrials.gov Identifier: NCT01433549
• Other Study ID Numbers: P-373-C-104
• First Posted: Sep 14, 2011
• Last Update Posted: May 6, 2013
• Last Verified: Apr 1, 2013

• Additional relevant MeSH terms: Myopia

Study Results

Participant Flow

Recruitment Details	Participants were recruited from one study center located in Canada.
Pre-assignment Detail	Of the 44 participants enrolled, 16 were exited from the study prior to randomization (screen failures). Three subjects were randomized/fitted with lenses but discontinued prior to product dispense. This reporting group includes all participants enrolled and dispensed product. A 12-hour lens-free wear period preceded each phase.

Arm/Group Title	Lotrafilcon B / Senofilcon A	Senofilcon A / Lotrafilcon B
Arm/Group Description	Lotrafilcon B worn first, with senofilcon A worn second, as randomized. Each product was worn bilaterally in 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes, over the course of a 12-hour day, for a total of 4 cycles (days).	Senofilcon A worn first, with lotrafilcon B worn second, as randomized. Each product was worn bilaterally in 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes, over the course of a 12-hour day, for a total of 4 cycles (days).
Period Title: Phase 1: First Study Product
STARTED	12	13
COMPLETED	12	13
NOT COMPLETED	0	0
Period Title: Phase 1: First Study Product
STARTED	12	13
COMPLETED	12	12
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	Overall
Arm/Group Description	Lotrafilcon B and Senofilcon A worn in cross-over fashion as randomized. Each product was worn bilaterally in 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes, over the course of a 12-hour day, for a total of 4 cycles (days).
Overall Participants	25
Age, Customized (years) [Median (Full Range) ]
Median (Full Range) [years]	25
Sex: Female, Male (Count of Participants)
Female	15 60%
Male	10 40%
Region of Enrollment (participants) [Number]
Canada	25 100%

Outcome Measures

1. Primary Outcome

Title	Mean End-of-Day Comfort
Description	As assessed by the participant using a visual analog scale ranging from 0 (extremely uncomfortable) to 100 (very comfortable and fresh) at the end of each 12-hour (approximate) cycle. During each cycle, contact lenses were worn for 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes. A new pair of contact lenses was dispensed for each 2-hour interval of lens wear.
Time Frame	Hour 12

Outcome Measure Data

Analysis Population Description

All participants who participated in both phases of the study.

Arm/Group Title	Lotrafilcon B	Senofilcon A
Arm/Group Description	Lotrafilcon B worn worn bilaterally in 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes, over the course of a 12-hour day, for a total of 4 cycles (days).	Senofilcon A worn bilaterally in 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes, over the course of a 12-hour day, for a total of 4 cycles (days).
Measure Participants	25	25
Six 2-hr wear intervals/0-min recovery intervals	48.9 (17.8)	56.0 (15.9)
Five 2-hr wear intervals/30-min recovery intervals	51.4 (17.6)	53.7 (15.9)
Four 2-hr wear intervals/60-min recovery intervals	56.0 (19.8)	58.8 (13.9)
Four 2-hr wear intervals/80-min recovery intervals	51.5 (13.1)	58.8 (18.0)

2. Secondary Outcome

Title	Mean Non-Invasive Tear Film Break-Up Time (NITBUT)
Description	As assessed by the investigator using a corneal topographer. NITBUT was assessed at the end of each 12-hour (approximate) cycle. During each cycle, contact lenses were worn for 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes. A new pair of contact lenses was dispensed for each 2-hour interval of lens wear. A longer tear film break-up time indicates a more stable tear film and may lead to a more comfortable lens-wearing experience.
Time Frame	Hour 12

Outcome Measure Data

Analysis Population Description

All participants who participated in both phases of the study.

Arm/Group Title	Lotrafilcon B	Senofilcon A
Arm/Group Description	Lotrafilcon B worn worn bilaterally in 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes, over the course of a 12-hour day, for a total of 4 cycles (days).	Senofilcon A worn bilaterally in 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes, over the course of a 12-hour day, for a total of 4 cycles (days).
Measure Participants	25	25
Six 2-hr wear intervals/0-min recovery intervals	4.6 (1.9)	4.3 (1.2)
Five 2-hr wear intervals/30-min recovery intervals	5.3 (2.2)	4.7 (2.4)
Four 2-hr wear intervals/60-min recovery intervals	4.4 (2.2)	4.4 (2.4)
Four 2-hr wear intervals/80-min recovery intervals	4.9 (2.6)	4.8 (2.2)

Adverse Events

Time Frame	Adverse events were collected for the duration of the study (6 months). The safety population is defined as all subjects exposed to product and includes three subjects randomized/fitted with lenses but discontinued prior to product dispense.
Adverse Event Reporting Description	The lens wear regimen in this study was not typical. The study protocol required multiple lens insertions and removals within a wear day, which may have negatively impacted ocular surface characteristics in some subjects.
Arm/Group Title	Lotrafilcon B		Senofilcon A
Arm/Group Description	Lotrafilcon B worn worn bilaterally in 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes, over the course of a 12-hour day, for a total of 4 cycles (days).		Senofilcon A worn bilaterally in 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes, over the course of a 12-hour day, for a total of 4 cycles (days).
All Cause Mortality
	Lotrafilcon B		Senofilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Lotrafilcon B		Senofilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/28 (0%)		0/28 (0%)
Other (Not Including Serious) Adverse Events
	Lotrafilcon B		Senofilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/28 (25%)		0/28 (0%)
Eye disorders
Redness with Indentation	5/28 (17.9%)		0/28 (0%)
Staining	3/28 (10.7%)		0/28 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

For a period of 10 years, the clinical investigator must hold all trial-related information and documents confidential and must obtain sponsor's written consent before discussing, presenting, publicizing, or otherwise disclosing any preclinical and/or clinical data or impressions from this trial.