Clinical Assessment of a Multifocal Contact Lens for People Who Use Reading Glasses Only

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Alcon Research ( CIBA VISION )

ClinicalTrials.gov Identifier:

NCT01268501

First received: December 29, 2010

Last updated: June 26, 2012

Last verified: February 2012

History of Changes

Results First Received: January 13, 2012

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Presbyopia
Intervention:	Device: Lotrafilcon B multifocal 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
A total of 103 participants were recruited at 25 US sites from December 8, 2010, to January 31, 2011.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Seven participants were enrolled in the study but not dispensed due to failing inclusion/exclusion criteria (1); withdrawing consent/disinterest (4); discomfort (1); and unacceptable subjective vision (1). These participants are included in the Actual Enrollment calculation, but not Participant Flow or Baseline Characteristics calculations.

Reporting Groups

	Description
Lotrafilcon B Multifocal	Lotrafilcon B multifocal contact lenses worn bilaterally for 3 weeks on a daily wear basis

Participant Flow: Overall Study

	Lotrafilcon B Multifocal
STARTED	96
COMPLETED	87
NOT COMPLETED	9
Lost to Follow-up	1
Withdrawal by Subject	3
Unacceptable Subjective Vision	3
Handling Difficulties	2

Baseline Characteristics

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Reporting Groups

	Description
Lotrafilcon B Multifocal	Lotrafilcon B multifocal contact lenses worn bilaterally for 3 weeks on a daily wear basis

Baseline Measures

	Lotrafilcon B Multifocal
Number of Participants [units: participants]	96
Age [units: years] Mean ± Standard Deviation	44.9 ± 2.7
Gender [units: participants]
Female	72
Male	24
Region of Enrollment [units: participants]
United States	96

Outcome Measures

1. Primary:

Overall Convenience With Contact Lenses [ Time Frame: 3 weeks 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
No text entered.

Results Point of Contact:

Name/Title: Director of Alcon Clinical
Organization: Alcon Research, Ltd.
phone: 1-800-241-7629

No publications provided

Responsible Party:	Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:	NCT01268501 History of Changes
Other Study ID Numbers:	P-319-C-019
Study First Received:	December 29, 2010
Results First Received:	January 13, 2012
Last Updated:	June 26, 2012
Health Authority:	United States: Institutional Review Board

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