Daily Disposable Toric Comparative Trial in Europe

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Alcon Research ( CIBA VISION )

ClinicalTrials.gov Identifier:

NCT01070381

First received: February 16, 2010

Last updated: June 26, 2012

Last verified: January 2012

History of Changes

Results First Received: February 25, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Myopia Astigmatism
Interventions:	Device: nelfilcon A contact lens Device: ocufilcon D contact lens

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
Three participants were enrolled but not dispensed due to failing inclusion/exclusion criteria. These participants were included in the Actual Enrollment calculation, but not Participant Flow or Baseline Characteristics calculations.

Reporting Groups

	Description
Nelfilcon A / Ocufilcon D	Nelfilcon A contact lenses worn first, with ocufilcon D contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.
Ocufilcon D / Nelfilcon A	Ocufilcon D contact lenses worn first, with nelfilcon A contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.

Participant Flow for 2 periods

Period 1: Period 1, 1 Week of Wear

	Nelfilcon A / Ocufilcon D	Ocufilcon D / Nelfilcon A
STARTED	109 ^[1]	107
COMPLETED	109 ^[2]	107
NOT COMPLETED	0	0

[1]	One subject could not be dispensed into Period 1 product. Subject started Period 2 wear.
[2]	One subject could not continue into Period 2 due to product unavailability.

Period 2: Period 2, 1 Week of Wear

	Nelfilcon A / Ocufilcon D	Ocufilcon D / Nelfilcon A
STARTED	109	107
COMPLETED	108	106
NOT COMPLETED	1	1
Handling	0	1
Unacceptable Vision	1	0

Baseline Characteristics

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Reporting Groups

	Description
Overall Study	This reporting group includes all enrolled and dispensed subjects

Baseline Measures

	Overall Study
Number of Participants [units: participants]	217
Age [units: years] Mean ± Standard Deviation	33.2 ± 9.4
Gender [units: participants]
Female	151
Male	66

Outcome Measures

1. Primary:

Overall Comfort [ Time Frame: 1 week of wear ]

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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: For a period of 10 years, the clinical investigator must hold all trial-related information and documents confidential and must agree to obtain sponsor's written consent before discussing, presenting, publicizing, or otherwise disclosing any preclinical and/or clinical data or impressions from this trial.

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: Priya Janakiraman, OD, FAAO / Head, Global Clinical Affairs
Organization: CIBA VISION
phone: 1-800-241-7629
e-mail: priya.janakiraman@cibavision.com

No publications provided

Responsible Party:	Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:	NCT01070381 History of Changes
Other Study ID Numbers:	P-346-C-008
Study First Received:	February 16, 2010
Results First Received:	February 25, 2011
Last Updated:	June 26, 2012
Health Authority:	Germany: Ethics Commission

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