Comparison of Two New Silicone Hydrogel Multifocal Products

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Alcon Research ( CIBA VISION )

ClinicalTrials.gov Identifier:

NCT00823615

First received: January 13, 2009

Last updated: June 26, 2012

Last verified: January 2012

History of Changes

Results First Received: September 7, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Single Blind (Subject); Primary Purpose: Treatment
Condition:	Presbyopia
Interventions:	Device: Lotrafilcon B multifocal contact lens Device: Senofilcon A 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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Two participants were enrolled but not dispensed due to failing inclusion criteria. These participants were included in the Actual Enrollment calculation, but not Participant Flow or Baseline Characteristics calculations.

Reporting Groups

	Description
Lotrafilcon B / Senofilcon A	Lotrafilcon B multifocal contact lens worn first, followed by Senofilcon A multifocal contact lens worn second. Both products were worn on a daily-wear basis.
Senofilcon A / Lotrafilcon B	Senofilcon A multifocal contact lens worn first, followed by Lotrafilcon B multifocal contact lens worn second. Both products were worn on a daily-wear basis.

Participant Flow for 2 periods

Period 1: Period 1

	Lotrafilcon B / Senofilcon A	Senofilcon A / Lotrafilcon B
STARTED	19	19
COMPLETED	19	19
NOT COMPLETED	0	0

Period 2: Period 2

	Lotrafilcon B / Senofilcon A	Senofilcon A / Lotrafilcon B
STARTED	19	19
COMPLETED	16	17
NOT COMPLETED	3	2
Lost to Follow-up	2	0
Time/Job Conflict	1	2

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]	38
Age [units: years] Mean ± Standard Deviation	47.6 ± 4.7
Gender [units: participants]
Female	30
Male	8

Outcome Measures

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1. Primary:

Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity [ Time Frame: After 1 week of wear ]

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2. Primary:

Corrected Near Binocular Visual Measurement in Normal Illumination Reported as Binocular Near Visual Acuity [ 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 pre-clinical 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:	NCT00823615 History of Changes
Other Study ID Numbers:	P-319-C-005 sub 7
Study First Received:	January 13, 2009
Results First Received:	September 7, 2010
Last Updated:	June 26, 2012
Health Authority:	United States: Institutional Review Board

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