Multifocal Contact Lens Use in Previous Contact Lens Wearers With Near Vision Demands (GARM)

This study has been completed.

Sponsor:

Collaborator:

University of Waterloo

Information provided by (Responsible Party):

Alcon Research ( CIBA VISION )

ClinicalTrials.gov Identifier:

NCT00965237

First received: August 24, 2009

Last updated: June 26, 2012

Last verified: January 2012

History of Changes

Results First Received: January 21, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Presbyopia
Interventions:	Device: lotrafilcon B multifocal contact lens Device: lotrafilcon B single vision contact lens Other: Over-reader spectacles

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
Multifocal CL / Single Vision CL+ Reading Glasses	Lotrafilcon B multifocal contact lenses (CL) worn first, with lotrafilcon B single vision contact lenses (CL) and over-reader spectacles worn second. Both contact lens products worn bilaterally on a daily wear basis; over-reader spectacles worn on an as-needed basis.
Single Vision CL + Reading Glasses / Multifocal CL	Lotrafilcon B single vision contact lenses (CL) and over-reader spectacles worn first, with lotrafilcon B multifocal contact lenses (CL) worn second. Both contact lens products worn bilaterally on a daily wear basis; over-reader spectacles worn on an as-needed basis.

Participant Flow for 2 periods

Period 1: Period 1, One Week of Wear

	Multifocal CL / Single Vision CL+ Reading Glasses	Single Vision CL + Reading Glasses / Multifocal CL
STARTED	8	8
COMPLETED	8	8
NOT COMPLETED	0	0

Period 2: Period 2, One Week of Wear

	Multifocal CL / Single Vision CL+ Reading Glasses	Single Vision CL + Reading Glasses / Multifocal CL
STARTED	8	8
COMPLETED	8	8
NOT COMPLETED	0	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]	16
Age [units: years] Mean ± Standard Deviation	48.3 ± 4.5
Gender [units: participants]
Female	12
Male	4

Outcome Measures

1. Primary:

Overall Satisfaction With the Lenses [ Time Frame: 1 week of wear ]

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Serious Adverse Events

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Other Adverse Events

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Time Frame	Adverse event data were collected for the duration of the trial. Individual subject exposure = 1 week per product, total 2 weeks.
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	5%

Reporting Groups

	Description
Multifocal Contact Lens	Commercially marketed lotrafilcon B multifocal contact lenses
Single Vision Contact Lens	Commercially marketed lotrafilcon B single vision contact lenses

Other Adverse Events

	Multifocal Contact Lens	Single Vision Contact Lens
Total, other (not including serious) adverse events
# participants affected / at risk	0/16	0/16

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: No distribution of trial-specific information without express written permission of director.

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:	NCT00965237 History of Changes
Other Study ID Numbers:	P-368-C-101
Study First Received:	August 24, 2009
Results First Received:	January 21, 2011
Last Updated:	June 26, 2012
Health Authority:	Canada: Ethics Review Committee

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