Clinical Evaluation of Two Daily Disposable Lenses in a Population of Daily Disposable (DD) Lens Wearers

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Alcon Research ( CIBA VISION )

ClinicalTrials.gov Identifier:

NCT00958828

First received: August 11, 2009

Last updated: June 26, 2012

Last verified: January 2012

History of Changes

Results First Received: September 23, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Single Blind (Subject); Primary Purpose: Treatment
Condition:	Myopia
Interventions:	Device: Nelfilcon A contact lens Device: Narafilcon A 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
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Reporting Groups

	Description
Nelfilcon A / Narafilcon A	Nelfilcon A contact lenses, then Narafilcon A contact lenses
Narafilcon A / Nelfilcon A	Narafilcon A contact lenses, then Nelfilcon A contact lenses

Participant Flow for 2 periods

Period 1: Period 1, 1 Week of Wear

	Nelfilcon A / Narafilcon A	Narafilcon A / Nelfilcon A
STARTED	89	89
COMPLETED	89	88
NOT COMPLETED	0	1
Randomization break	0	1

Period 2: Period 2, 1 Week of Wear

	Nelfilcon A / Narafilcon A	Narafilcon A / Nelfilcon A
STARTED	89	88
COMPLETED	89	87
NOT COMPLETED	0	1
Unacceptable lens fit	0	1

Baseline Characteristics

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Reporting Groups

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

Baseline Measures

	Overall
Number of Participants [units: participants]	178
Age [units: years] Mean ± Standard Deviation	30.0 ± 12.1
Gender [units: participants]
Female	111
Male	67

Outcome Measures

1. Primary:

Overall Lens Satisfaction [ Time Frame: After 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:	NCT00958828 History of Changes
Other Study ID Numbers:	P-337-C-028
Study First Received:	August 11, 2009
Results First Received:	September 23, 2010
Last Updated:	June 26, 2012
Health Authority:	United States: Institutional Review Board

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