SILVER: Evaluation of Silicone Hydrogel Lens Wettability With Marketed Lens Care Solutions

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01252134
• Collaborator: (none)
• Enrollment: 22
• Arms: 6
• Duration (Months): 3

Study Details

Study Description

Brief Summary

The purpose of this study is to assess ex vivo wettability of a commonly prescribed silicone hydrogel (SiH) contact lens with three marketed contact lens care solutions.

Condition or Disease	Intervention/Treatment	Phase
Contact Lens Wear	Device: Biotrue multipurpose solution; Device: Sauflon Synergi multipurpose solution; Device: OTE Elements multipurpose solution; Device: Silicone hydrogel contact lenses (Acuvue Advance)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 22 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Supportive Care
• Official Title: The Evaluation of Silicone Hydrogel Lens Wettability With Marketed Lens Care Solutions
• Study Start Date: Nov 1, 2010
• Actual Primary Completion Date: Feb 1, 2011
• Actual Study Completion Date: Feb 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Other: Synergi, then Biotrue, then OTE Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.	Device: Biotrue multipurpose solution; Contact lens care solution; Device: Sauflon Synergi multipurpose solution; Contact lens care solution; Device: OTE Elements multipurpose solution; Contact lens care solution; Device: Silicone hydrogel contact lenses (Acuvue Advance); Commercially marketed contact lenses; Other Names: Acuvue® Advance™
Other: Synergi, then OTE, then Biotrue Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.	Device: Biotrue multipurpose solution; Contact lens care solution; Device: Sauflon Synergi multipurpose solution; Contact lens care solution; Device: OTE Elements multipurpose solution; Contact lens care solution; Device: Silicone hydrogel contact lenses (Acuvue Advance); Commercially marketed contact lenses; Other Names: Acuvue® Advance™
Other: Biotrue, then OTE, then Synergi Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.	Device: Biotrue multipurpose solution; Contact lens care solution; Device: Sauflon Synergi multipurpose solution; Contact lens care solution; Device: OTE Elements multipurpose solution; Contact lens care solution; Device: Silicone hydrogel contact lenses (Acuvue Advance); Commercially marketed contact lenses; Other Names: Acuvue® Advance™
Other: Biotrue, then Synergi, then OTE Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.	Device: Biotrue multipurpose solution; Contact lens care solution; Device: Sauflon Synergi multipurpose solution; Contact lens care solution; Device: OTE Elements multipurpose solution; Contact lens care solution; Device: Silicone hydrogel contact lenses (Acuvue Advance); Commercially marketed contact lenses; Other Names: Acuvue® Advance™
Other: OTE, then Biotrue, then Synergi Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.	Device: Biotrue multipurpose solution; Contact lens care solution; Device: Sauflon Synergi multipurpose solution; Contact lens care solution; Device: OTE Elements multipurpose solution; Contact lens care solution; Device: Silicone hydrogel contact lenses (Acuvue Advance); Commercially marketed contact lenses; Other Names: Acuvue® Advance™
Other: OTE, then Synergi, then Biotrue Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.	Device: Biotrue multipurpose solution; Contact lens care solution; Device: Sauflon Synergi multipurpose solution; Contact lens care solution; Device: OTE Elements multipurpose solution; Contact lens care solution; Device: Silicone hydrogel contact lenses (Acuvue Advance); Commercially marketed contact lenses; Other Names: Acuvue® Advance™

Outcome Measures

Primary Outcome Measures

1. Ex Vivo Contact Angle [8 hours]

   Study lens was removed from the eye according to protocol-specified procedures. The OCA15 Dynamic Contact Angle Instrument was used to observe, record, and calculate contact angle measurements. The measurements from the right eye and left eye were averaged. A lower contact angle measurement indicates a more wettable lens.

Secondary Outcome Measures

1. Subjective Comfort [8 hours]

   Subjective comfort was assessed by the participant on a scale of 0 to 100, with 0 being very poor comfort and 100 being excellent comfort. The ratings for the right eye and left eye were averaged.

2. Corneal Staining Type [8 hours]

   Five regions of the cornea (central, inferior, temporal, superior, and nasal) were evaluated for staining using cobalt light and a #12 Wratten filter. The type of staining was recorded on a scale of 0 to 100 for each corneal region with 0-none, 25=micropunctate, 50=macropunctate, 75=coalescent, and 100=patch. The five regions for each eye were averaged, and the eyes were averaged.

3. Corneal Staining Extent [8 hours]

   Area (extent) of corneal staining was estimated for each of the five regions of the cornea as a percentage i.e., 0%=no staining in the region and 100%=staining covering the entire region). A staining area percentage was calculated for each eye based on the average staining area measured across all five regions, and the eyes were averaged.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• 18 years of age

• Soft contact lens wear on a daily wear basis

• Able to wear lenses at least 8 hours

• Generally healthy with normal ocular health

• Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

• Use of additional lens cleaners

• Known sensitivities to any ingredient in any of the study products

• History of ocular surgery/trauma within the last 6 months

• Other protocol-defined exclusion criteria may apply

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Alcon Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT01252134
• Other Study ID Numbers: RDG10078 / SILVER
• First Posted: Dec 2, 2010
• Last Update Posted: Jun 11, 2012
• Last Verified: May 1, 2012

• Keywords provided by Alcon Research: Soft Contact lens; Multi-purpose solution; Wettability
• Additional relevant MeSH terms: Pharmaceutical Solutions

Study Results

Participant Flow

Recruitment Details	Participants were recruited and enrolled from one Canadian study center.

Arm/Group Title	Synergi, Then Biotrue, Then OTE	Synergi, Then OTE, Then Biotrue	Biotrue, Then OTE, Then Synergi	Biotrue, Then Synergi, Then OTE	OTE, Then Biotrue, Then Synergi	OTE, Then Synergi, Then Biotrue
Arm/Group Description	Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.	Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.	Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.	Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.	Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.	Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.
Period Title: Period 1, 8 Hours
STARTED	3	4	3	5	3	4
COMPLETED	3	3	2	5	3	4
NOT COMPLETED	0	1	1	0	0	0
Period Title: Period 1, 8 Hours
STARTED	3	3	2	5	3	4
COMPLETED	3	3	2	5	3	4
NOT COMPLETED	0	0	0	0	0	0
Period Title: Period 1, 8 Hours
STARTED	3	3	2	5	3	4
COMPLETED	3	3	2	5	3	4
NOT COMPLETED	0	0	0	0	0	0

Baseline Characteristics

Arm/Group Title	Overall
Arm/Group Description	All enrolled participants
Overall Participants	22
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	24.8 (9.5)
Sex: Female, Male (Count of Participants)
Female	13 59.1%
Male	9 40.9%

Outcome Measures

1. Primary Outcome

Title	Ex Vivo Contact Angle
Description	Study lens was removed from the eye according to protocol-specified procedures. The OCA15 Dynamic Contact Angle Instrument was used to observe, record, and calculate contact angle measurements. The measurements from the right eye and left eye were averaged. A lower contact angle measurement indicates a more wettable lens.
Time Frame	8 hours

Outcome Measure Data

Analysis Population Description

This reporting group includes all participants who completed the study, minus one response in Synergi group due to a measurement error.

Arm/Group Title	Synergi	Bio-True	OTE Elements
Arm/Group Description	Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.	Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.	Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.
Measure Participants	19	20	20
Mean (Standard Deviation) [degrees]	104.8 (2.4)	104.9 (3.7)	103.3 (5.4)

2. Secondary Outcome

Title	Subjective Comfort
Description	Subjective comfort was assessed by the participant on a scale of 0 to 100, with 0 being very poor comfort and 100 being excellent comfort. The ratings for the right eye and left eye were averaged.
Time Frame	8 hours

Outcome Measure Data

Analysis Population Description

This reporting group includes all participants who completed the study.

Arm/Group Title	Synergi	Bio-True	OTE Elements
Arm/Group Description	Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.	Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.	Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.
Measure Participants	20	20	20
Mean (Standard Deviation) [Units on a scale]	87.3 (7.9)	87.3 (10.2)	86.4 (15.0)

3. Secondary Outcome

Title	Corneal Staining Type
Description	Five regions of the cornea (central, inferior, temporal, superior, and nasal) were evaluated for staining using cobalt light and a #12 Wratten filter. The type of staining was recorded on a scale of 0 to 100 for each corneal region with 0-none, 25=micropunctate, 50=macropunctate, 75=coalescent, and 100=patch. The five regions for each eye were averaged, and the eyes were averaged.
Time Frame	8 hours

Outcome Measure Data

Analysis Population Description

This reporting group includes all participants who completed the study.

Arm/Group Title	Synergi	Bio-True	OTE Elements
Arm/Group Description	Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.	Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.	Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.
Measure Participants	20	20	20
Mean (Standard Deviation) [Units on a scale]	5.4 (8.4)	8.8 (8.4)	3.0 (4.7)

4. Secondary Outcome

Title	Corneal Staining Extent
Description	Area (extent) of corneal staining was estimated for each of the five regions of the cornea as a percentage i.e., 0%=no staining in the region and 100%=staining covering the entire region). A staining area percentage was calculated for each eye based on the average staining area measured across all five regions, and the eyes were averaged.
Time Frame	8 hours

Outcome Measure Data

Analysis Population Description

This reporting group includes all participants who completed the study.

Arm/Group Title	Synergi	Bio-True	OTE Elements
Arm/Group Description	Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.	Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.	Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.
Measure Participants	20	20	20
Mean (Standard Deviation) [percentage of cornea]	0.7 (0.8)	3.1 (3.8)	0.9 (4.7)

Adverse Events

Time Frame	Adverse events were collected for the duration of the trial: 24-NOV-2010 to 8-FEB-2011.
Adverse Event Reporting Description	This reporting group includes all enrolled and exposed participants
Arm/Group Title	Synergi		Bio-True		OTE Elements
Arm/Group Description	Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.		Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.		Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.
All Cause Mortality
	Synergi		Bio-True		OTE Elements
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Synergi		Bio-True		OTE Elements
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/21 (0%)		0/21 (0%)		0/20 (0%)
Other (Not Including Serious) Adverse Events
	Synergi		Bio-True		OTE Elements
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/21 (0%)		0/21 (0%)		0/20 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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