Evaluation of Deposits on Contact Lenses Worn Extended Wear

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Alcon Research

ClinicalTrials.gov Identifier:

NCT00725530

First received: July 28, 2008

Last updated: July 19, 2012

Last verified: July 2012

History of Changes

Results First Received: September 25, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Single Blind (Subject)
Condition:	Myopia
Interventions:	Device: balafilcon A contact lens (PureVision) Device: etafilcon A contact lens (Acuvue2)

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
Each site enrolled normal participants (non-depositors) and depositors in approximately a 1:1 ratio, as outlined in the protocol. 54 participants in 3 US sites and 1 UK site were enrolled.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants meeting eligibility criteria at the screening visit were enrolled into the study. 48 hours of no lens wear prior to Visit 1 served as the washout period. This reporting group includes all enrolled and dispensed participants.

Reporting Groups

	Description
Balafilcon A / Etafilcon A	Balafilcon A worn first, with etafilcon A worn second. Each product worn bilaterally in an extended wear (overnight) basis for 7 days.
Etafilcon A / Balafilcon A	Etafilcon A worn first, with balafilcon A worn second. Each product worn bilaterally in an extended wear (overnight) basis for 7 days.

Participant Flow for 2 periods

Period 1: First Intervention, 7 Days (+0/-1)

	Balafilcon A / Etafilcon A	Etafilcon A / Balafilcon A
STARTED	27	27
COMPLETED	27	27
NOT COMPLETED	0	0

Period 2: Second Intervention, 7 Days (+0/-1)

	Balafilcon A / Etafilcon A	Etafilcon A / Balafilcon A
STARTED	27	27
COMPLETED	27	27
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
Overall	This reporting group includes all enrolled and dispensed participants.

Baseline Measures

	Overall
Number of Participants [units: participants]	54
Age [units: years] Mean ± Standard Deviation	32.35 ± 12.71
Gender [units: participants]
Female	42
Male	12

Outcome Measures

1. Primary:

Front Surface Lens Deposits [ Time Frame: 7 days ]

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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.

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
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Results Point of Contact:

Name/Title: Director of Alcon Clinical
Organization: Alcon Research, Ltd.
phone: 888.451.3937; 817.568.6725
e-mail: medinfo@alconlabs.com

No publications provided

Responsible Party:	Alcon Research
ClinicalTrials.gov Identifier:	NCT00725530 History of Changes
Other Study ID Numbers:	MS-007
Study First Received:	July 28, 2008
Results First Received:	September 25, 2009
Last Updated:	July 19, 2012
Health Authority:	United States: Institutional Review Board United Kingdom: Research Ethics Committee

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