Comparative In-Vivo Wetting Characteristics of Silicone Hydrogel Materials With Selected Lens Care Systems

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01699750
• Collaborator: (none)
• Enrollment: 109
• Location: 1
• Arms: 2
• Duration (Months): 11
• Patients Per Site Per Month: 9.9

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the lipid uptake, wetting characteristics, and visual performance of AIR OPTIX® AQUA and ACUVUE® OASYS® with HYDRACLEAR® contact lenses when used in conjunction with two contact lens care systems.

Condition or Disease	Intervention/Treatment	Phase
Myopia; Astigmatism; Refractive Error	Device: Lotrafilcon B contact lenses; Device: Senofilcon A contact lenses; Device: OPTI-FREE® PUREMOIST® MPDS; Device: BIOTRUE®; Device: Balafilcon A contact lenses; Device: ReNu® Multiplus®	N/A

Detailed Description

This study will be divided into two phases. In the Pre-Investigational Phase (Phase 1), participants will wear PureVision contact lenses for 30 days and use ReNu® Multiplus® for contact lens care. Eligible participants will continue into the Investigational Phase (Phase 2) and be randomly assigned to wear AIR OPTIX® AQUA contact lenses or ACUVUE® OASYS® with HYDRACLEAR® contact lenses for a total of two months. For contact lens care, participants will use OPTI-FREE® PUREMOIST® MPDS and BIOTRUE® for 30 days each.

Study Design

• Study Type: Interventional
• Actual Enrollment: 109 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Official Title: Comparative In-Vivo Wetting Characteristics of Silicone Hydrogel Materials With Selected Lens Care Systems
• Study Start Date: Dec 1, 2012
• Actual Primary Completion Date: Nov 1, 2013
• Actual Study Completion Date: Nov 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Air Optix Aqua Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each	Device: Lotrafilcon B contact lenses; Silicone hydrogel contact lenses, Phase 2; Other Names: AIR OPTIX® AQUA AOA ; Device: OPTI-FREE® PUREMOIST® MPDS; Contact lens care system, Phase 2; Other Names: OFPM ; Device: BIOTRUE®; Contact lens care system, Phase 2; Device: Balafilcon A contact lenses; Silicone hydrogel contact lenses worn for 30 days, Phase 1; Other Names: PureVision ; Device: ReNu® Multiplus®; Contact lens care system used for 30 days, Phase 1
Active Comparator: Acuvue Oasys Senofilcon A contact lenses with OFPM and BIOTRUE for 30 days each	Device: Senofilcon A contact lenses; Silicone hydrogel contact lenses, Phase 2; Other Names: ACUVUE® OASYS® with HYDRACLEAR® AVO ; Device: OPTI-FREE® PUREMOIST® MPDS; Contact lens care system, Phase 2; Other Names: OFPM ; Device: BIOTRUE®; Contact lens care system, Phase 2; Device: Balafilcon A contact lenses; Silicone hydrogel contact lenses worn for 30 days, Phase 1; Other Names: PureVision ; Device: ReNu® Multiplus®; Contact lens care system used for 30 days, Phase 1

Outcome Measures

Primary Outcome Measures

1. Mean Ex-Vivo Total Lipid Uptake Per Lens [Day 30]

   The contact lens was aseptically removed from the eye. Lipids were extracted and analyzed using a proprietary High Performance Liquid Chromatography technique. A lower value indicates a cleaner lens surface. One eye (study eye) contributed to the mean.

Secondary Outcome Measures

1. Mean Non-Invasive Pre-Lens Tear Film Break Up Time (NIBUT) [Day 30]

   The pre-lens tear film is the layer of tears located on top of the contact lens between the eyelid and the contact lens. NIBUT (i.e., the time elapsed between eye opening after a blink and the appearance of the first dark spot within the tear film) was measured using a diffuse illumination source (Tearscope) and videotography. A longer NIBUT indicates a more stable tear film and greater on-eye lens wettability. One eye (study eye) contributed to the mean.

2. LogMAR Time-Controlled Visual Acuity (TCVA) [Day 30]

   Visual performance was measured binocularly (both eyes together) at two contrast levels using a validated Time Controlled Visual Acuity test (TCVA). TCVA was recorded in VA units (1 VA unit=1 VA line=0.1 logMAR), with positive (+) values corresponding with VA better than 20/20 and negative (-) values worse than 20/20.

3. Overall Comfort Measured With Visual Analog Scale (VAS) [Day 30]

   The participant rated overall comfort on a 100-millimeter analog scale by marking a line that best corresponds to their eye comfort (0=very poor, 100=excellent). Both eyes were rated together as a single, retrospective evaluation of the previous 3 days of wear.

4. Overall Dryness Measured With Visual Analog Scale (VAS) [Day 30]

   The participant rated overall dryness on a 100-millimeter analog scale by marking a line that best describes how dry their eyes feel (0=not at all dry, 100=very dry). Both eyes were rated together as a single, retrospective evaluation of the previous 3 days of wear.

5. Average Exposure Speed [Day 30]

   Exposure speed (rate of increase in exposed lens surface % (areas not protected by tear film) after the first tear film break and before the second blink) was measured with a diffuse illumination source (Tearscope) and videotography. Higher speeds indicate worse tear film dynamics. One eye (study eye) contributed to the mean.

6. Minimum Protected Area [Day 30]

   Minimum protected area (i.e., minimum area of the lens (%) covered by the tear film during the interblink period) was measured using a diffuse illumination source (Tearscope) and videotography. A higher value indicates a larger area of the tearfilm spread evenly over the lens (i.e., less area of tear film breakage). One eye (study eye) contributed to the mean.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Read and understand the Participant Information Sheet;

• Read, sign, and date the Informed Consent;

• Be a current silicone hydrogel contact lens wearer using the contact lenses under a frequent replacement (bi-weekly or monthly) daily wear modality;

• Be classified as symptomatic and a depositor at the end of the replacement period according to protocol-specified criteria;

• Agree to wear study contact lenses as directed for the duration of the study and maintain the appointment schedule;

• Best corrected visual acuity of 6/9 or better in each eye;

• Normal eyes with the exception of the need for visual correction;

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Known sensitivity or intolerance to any of the contact lenses or contact lens care products to be used;

• Monocular vision (only one eye with functional vision or only one eye fitted with contact lenses);

• Use of systemic medication which might interfere with contact lens wear or produce dry eye side effects;

• Systemic disease which might interfere with contact lens wear or produce dry eye side effects;

• Systemic or ocular allergies which might interfere with contact lens wear;

• Ocular disease which might interfere with contact lens wear;

• Active ocular infection;

• Use of any concomitant topical ocular medications during the study period;

• Previous ocular surgery;

• Pregnant, planning to become pregnant, or lactating at the time of enrollment;

• Participation in an investigational drug or device study within 30 days of entering this study;

• Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Contact Alcon Call Center at 1-888-451-3937 for Trial Locations	Fort Worth	Texas	United States	76134

Sponsors and Collaborators

• Alcon Research

Investigators

• Study Director: Jami Kern, PhD, Alcon Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT01699750
• Other Study ID Numbers: M-12-043 / ID11-59
• First Posted: Oct 4, 2012
• Last Update Posted: Dec 8, 2014
• Last Verified: Dec 1, 2014

• Keywords provided by Alcon Research: contact lenses; contact lens solution; myopia; astigmatism
• Additional relevant MeSH terms: Myopia; Astigmatism; Refractive Errors

Study Results

Participant Flow

Recruitment Details	Participants were recruited from 1 study center located in the United Kingdom.
Pre-assignment Detail	Of the 109 participants enrolled, 39 were exited from the study prior to randomization and product dispense (Phase 2). This reporting group includes all randomized and dispensed participants (70).

Arm/Group Title	Air Optix Aqua	Acuvue Oasys
Arm/Group Description	Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each	Senofilcon A contact lenses with OFPM and BIOTRUE for 30 days each
Period Title: Overall Study
STARTED	34	36
COMPLETED	34	33
NOT COMPLETED	0	3

Baseline Characteristics

Arm/Group Title	Air Optix Aqua	Acuvue Oasys	Total
Arm/Group Description	Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each	Senofilcon A contact lenses with OFPM and BIOTRUE for 30 days each	Total of all reporting groups
Overall Participants	34	36	70
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	36.0 (10.95)	35.3 (8.77)	35.6 (9.82)
Sex: Female, Male (Count of Participants)
Female	24 70.6%	29 80.6%	53 75.7%
Male	10 29.4%	7 19.4%	17 24.3%

Outcome Measures

1. Primary Outcome

Title	Mean Ex-Vivo Total Lipid Uptake Per Lens
Description	The contact lens was aseptically removed from the eye. Lipids were extracted and analyzed using a proprietary High Performance Liquid Chromatography technique. A lower value indicates a cleaner lens surface. One eye (study eye) contributed to the mean.
Time Frame	Day 30

Outcome Measure Data

Analysis Population Description

This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy endpoint. Two Day 30 measurements per participant (one eye per Day 30) contributed to analysis.

Arm/Group Title	Air Optix Aqua	Acuvue Oasys
Arm/Group Description	Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each	Senofilcon A contact lenses with OFPM and BIOTRUE for 30 days each
Measure Participants	34	33
Geometric Mean (Standard Deviation) [micrograms]	7.198 (1.5014)	35.879 (1.8185)

2. Secondary Outcome

Title	Mean Non-Invasive Pre-Lens Tear Film Break Up Time (NIBUT)
Description	The pre-lens tear film is the layer of tears located on top of the contact lens between the eyelid and the contact lens. NIBUT (i.e., the time elapsed between eye opening after a blink and the appearance of the first dark spot within the tear film) was measured using a diffuse illumination source (Tearscope) and videotography. A longer NIBUT indicates a more stable tear film and greater on-eye lens wettability. One eye (study eye) contributed to the mean.
Time Frame	Day 30

Outcome Measure Data

Analysis Population Description

This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy endpoint. Two Day 30 measurements per participant (one eye per Day 30) contributed to analysis.

Arm/Group Title	Air Optix Aqua	Acuvue Oasys
Arm/Group Description	Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each	Senofilcon A contact lenses with OFPM and BIOTRUE for 30 days each
Measure Participants	34	33
Geometric Mean (Standard Deviation) [seconds]	3.316 (2.6913)	2.918 (2.4859)

3. Secondary Outcome

Title	LogMAR Time-Controlled Visual Acuity (TCVA)
Description	Visual performance was measured binocularly (both eyes together) at two contrast levels using a validated Time Controlled Visual Acuity test (TCVA). TCVA was recorded in VA units (1 VA unit=1 VA line=0.1 logMAR), with positive (+) values corresponding with VA better than 20/20 and negative (-) values worse than 20/20.
Time Frame	Day 30

Outcome Measure Data

Analysis Population Description

This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy. Two Day 30 measurements per participant contributed to analysis.

Arm/Group Title	Air Optix Aqua	Acuvue Oasys
Arm/Group Description	Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each	Senofilcon A contact lenses with OFPM and BIOTRUE for 30 days each
Measure Participants	34	33
High Contrast	0.38 (1.058)	-0.14 (0.999)
Low Contrast	-1.15 (1.213)	-1.60 (1.040)

4. Secondary Outcome

Title	Overall Comfort Measured With Visual Analog Scale (VAS)
Description	The participant rated overall comfort on a 100-millimeter analog scale by marking a line that best corresponds to their eye comfort (0=very poor, 100=excellent). Both eyes were rated together as a single, retrospective evaluation of the previous 3 days of wear.
Time Frame	Day 30

Outcome Measure Data

Analysis Population Description

This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy endpoint.

Arm/Group Title	OFPM With Air Optix Aqua	OFPM With Acuvue Oasys	BIOTRUE With Air Optix Aqua	BIOTRUE With Acuvue Oasys
Arm/Group Description	OFPM with lotrafilcon B contact lenses for 30 days	OFPM with senofilcon A contact lenses for 30 days	BIOTRUE with lotrafilcon B contact lenses for 30 days	BIOTRUE with senofilcon A contact lenses for 30 days
Measure Participants	34	33	34	33
Mean (Standard Deviation) [units on a scale]	77.1 (20.25)	81.1 (20.37)	74.9 (28.43)	82.2 (20.76)

5. Secondary Outcome

Title	Overall Dryness Measured With Visual Analog Scale (VAS)
Description	The participant rated overall dryness on a 100-millimeter analog scale by marking a line that best describes how dry their eyes feel (0=not at all dry, 100=very dry). Both eyes were rated together as a single, retrospective evaluation of the previous 3 days of wear.
Time Frame	Day 30

Outcome Measure Data

Analysis Population Description

This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy endpoint.

Arm/Group Title	OFPM With Air Optix Aqua	OFPM With Acuvue Oasys	BIOTRUE With Air Optix Aqua	BIOTRUE With Acuvue Oasys
Arm/Group Description	OFPM with lotrafilcon B contact lenses for 30 days	OFPM with senofilcon A contact lenses for 30 days	BIOTRUE with lotrafilcon B contact lenses for 30 days	BIOTRUE with senofilcon A contact lenses for 30 days
Measure Participants	34	33	34	33
Mean (Standard Deviation) [units on a scale]	21.8 (20.41)	22.2 (22.15)	23.3 (25.65)	22.5 (25.60)

6. Secondary Outcome

Title	Average Exposure Speed
Description	Exposure speed (rate of increase in exposed lens surface % (areas not protected by tear film) after the first tear film break and before the second blink) was measured with a diffuse illumination source (Tearscope) and videotography. Higher speeds indicate worse tear film dynamics. One eye (study eye) contributed to the mean.
Time Frame	Day 30

Outcome Measure Data

Analysis Population Description

This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy endpoint. Two Day 30 measurements per participant (one eye per Day 30) contributed to analysis.

Arm/Group Title	Air Optix Aqua	Acuvue Oasys
Arm/Group Description	Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each	Senofilcon A contact lenses with OFPM and BIOTRUE for 30 days each
Measure Participants	34	33
Geometric Mean (Standard Deviation) [percent of area exposed/second]	0.059 (15.1175)	0.105 (24.4808)

7. Secondary Outcome

Title	Minimum Protected Area
Description	Minimum protected area (i.e., minimum area of the lens (%) covered by the tear film during the interblink period) was measured using a diffuse illumination source (Tearscope) and videotography. A higher value indicates a larger area of the tearfilm spread evenly over the lens (i.e., less area of tear film breakage). One eye (study eye) contributed to the mean.
Time Frame	Day 30

Outcome Measure Data

Analysis Population Description

This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy endpoint. Two Day 30 measurements per participant (one eye per Day 30) contributed to analysis.

Arm/Group Title	Air Optix Aqua	Acuvue Oasys
Arm/Group Description	Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each	Senofilcon A contact lenses with OFPM and BIOTRUE for 30 days each
Measure Participants	34	33
Mean (Standard Deviation) [percentage of lens surface covered]	90.75 (15.990)	77.79 (31.547)

Adverse Events

Time Frame	Adverse events were collected for the duration of the study (December 2012-November 2013).This analysis group includes all participants randomized into the Investigational Phase of the study who participated in at least one period of the study.
Adverse Event Reporting Description	An adverse event was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device.
Arm/Group Title	AIR OPTIX AQUA		ACUVUE OASYS With HYDRACLEAR
Arm/Group Description	Lotrafilcon B contact lenses worn for 60 days, replaced monthly		Senofilcon A contact lenses worn for 60 days, replaced biweekly
All Cause Mortality
	AIR OPTIX AQUA		ACUVUE OASYS With HYDRACLEAR
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	AIR OPTIX AQUA		ACUVUE OASYS With HYDRACLEAR
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/34 (0%)		0/36 (0%)
Other (Not Including Serious) Adverse Events
	AIR OPTIX AQUA		ACUVUE OASYS With HYDRACLEAR
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/34 (8.8%)		7/36 (19.4%)
General disorders
Eye complication associated with device	0/34 (0%)		3/36 (8.3%)
Infections and infestations
Nasopharyngitis	3/34 (8.8%)		3/36 (8.3%)
Respiratory, thoracic and mediastinal disorders
Cough	0/34 (0%)		2/36 (5.6%)

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.