Evaluation of Silicone Hydrogel Lens Wettability With Marketed Lens Care Solutions (SILVER)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Alcon Research

ClinicalTrials.gov Identifier:

NCT01252134

First received: December 1, 2010

Last updated: May 8, 2012

Last verified: May 2012

History of Changes

Results First Received: May 8, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Supportive Care
Condition:	Contact Lens Wear
Interventions:	Device: Biotrue multipurpose solution Device: Sauflon Synergi multipurpose solution Device: OTE Elements multipurpose solution Device: Silicone hydrogel contact lenses (Acuvue Advance)

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited and enrolled from one Canadian study center.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
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.
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.
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.
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.
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.
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.

Participant Flow for 3 periods

Period 1: Period 1, 8 Hours

	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
STARTED	3	4	3	5	3	4
COMPLETED	3	3	2	5	3	4
NOT COMPLETED	0	1	1	0	0	0
Personal Reasons	0	1	1	0	0	0

Period 2: Period 2, 8 Hours

	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
STARTED	3	3	2	5	3	4
COMPLETED	3	3	2	5	3	4
NOT COMPLETED	0	0	0	0	0	0

Period 3: Period 3, 8 Hours

	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
STARTED	3	3	2	5	3	4
COMPLETED	3	3	2	5	3	4
NOT COMPLETED	0	0	0	0	0	0

Baseline Characteristics

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Reporting Groups

	Description
Overall	All enrolled participants

Baseline Measures

	Overall
Number of Participants [units: participants]	22
Age [units: years] Mean ± Standard Deviation	24.8 ± 9.5
Gender [units: participants]
Female	13
Male	9

Outcome Measures

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1. Primary:

Ex Vivo Contact Angle [ Time Frame: 8 hours ]

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2. Secondary:

Subjective Comfort [ Time Frame: 8 hours ]

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3. Secondary:

Corneal Staining Type [ Time Frame: 8 hours ]

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4. Secondary:

Corneal Staining Extent [ Time Frame: 8 hours ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

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

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: No text entered.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Director of Medical Affairs
Organization: Alcon Research, Ltd.
phone: 888.451.3937
e-mail: medinfo@alconlabs.com

No publications provided

Responsible Party:	Alcon Research
ClinicalTrials.gov Identifier:	NCT01252134 History of Changes
Other Study ID Numbers:	RDG10078 / SILVER
Study First Received:	December 1, 2010
Results First Received:	May 8, 2012
Last Updated:	May 8, 2012
Health Authority:	Canada: Ethics Review Committee

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