Evaluation of Two Toric Soft Contact Lenses and a Spherical Soft Contact Lens After Two Weeks of Wear

This study has been completed.

Sponsor:

Collaborator:

Foresight Regulatory Strategies, Inc.

Information provided by:

Vistakon

ClinicalTrials.gov Identifier:

NCT00584220

First received: December 20, 2007

Last updated: January 28, 2010

Last verified: January 2010

History of Changes

Results First Received: August 21, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Single Blind (Subject); Primary Purpose: Treatment
Condition:	Astigmatism
Interventions:	Device: senofilcon A toric Device: alphafilcon A toric

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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Senofilcon A / Alphafilcon A	senofilcon A toric silicone hydrogel contact lenses worn first, alphafilcon A toric hydrogel contact lenses worn second
Alphafilcon A / Senofilcon A	alphafilcon A toric hydrogel contact lenses worn first, senofilcon A toric silicone hydrogel contact lenses worn second

Participant Flow for 2 periods

Period 1: First Period

	Senofilcon A / Alphafilcon A	Alphafilcon A / Senofilcon A
STARTED	56	39
COMPLETED	56	39
NOT COMPLETED	0	0

Period 2: Second Period

	Senofilcon A / Alphafilcon A	Alphafilcon A / Senofilcon A
STARTED	56	39
COMPLETED	54	39
NOT COMPLETED	2	0
Protocol Violation	1	0
Subject disinterest	1	0

Baseline Characteristics

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Reporting Groups

	Description
Entire Study Population	N excluded from analysis: 6 for protocol violations and ineligible

Baseline Measures

	Entire Study Population
Number of Participants [units: participants]	93
Age [units: years] Mean ± Standard Deviation	27.9 ± 5.9
Gender [units: participants]
Female	56
Male	37

Outcome Measures

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1. Primary:

Patient Reported Vision [ Time Frame: measured at 1-wk and measured at 2-wks ]

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2. Primary:

Patient Reported Lens Comfort. [ Time Frame: measured at 1-wk and measured at 2-wks ]

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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: The PI may not publish, divulge, reveal, disclose, or use the data and or results of the study without prior written consent of Vistakon.

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: Kurt Moody, OD, FAAO
Organization: Vistakon
phone: 904-443-3088
e-mail: kmoody1@its.jnj.com

No publications provided

Responsible Party:	Kurt Moody, OD, FAAO./ Manager, Clinical Research, Vistakon
ClinicalTrials.gov Identifier:	NCT00584220 History of Changes
Other Study ID Numbers:	CR-0714B
Study First Received:	December 20, 2007
Results First Received:	August 21, 2009
Last Updated:	January 28, 2010
Health Authority:	United States: Institutional Review Board

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