Comparison of a New Abbott Medical Optics (AMO) Multi-Purpose Solution (MPS) to Existing Contact Lens Regimens

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Abbott Medical Optics

ClinicalTrials.gov Identifier:

NCT01294917

First received: February 10, 2011

Last updated: May 18, 2012

Last verified: May 2012

History of Changes

Results First Received: February 15, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Single Blind (Investigator)
Condition:	Normal Contact Lens Wearers.
Interventions:	Device: Multi-purpose disinfecting solution Device: Clear Care Device: Opti-Free RepleniSH

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
All Participants	All subjects received each of 3 study solutions for one month each for the daily care of their soft contact lenses. Subjects were randomized to six possible sequences of use of each study solution: AMO Investigational MPS, Clear Care and OptiFree ReplenisH MPS.

Participant Flow: Overall Study

	All Participants
STARTED	42
Received Investigational MPS	36
Received Clear Care	36
Received OptiFree RepleniSH MPS	36
COMPLETED	36
NOT COMPLETED	6
Relocation	5
Inconvenience	1

Baseline Characteristics

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Reporting Groups

	Description
All Participants	All subjects received each of 3 study solutions for one month each for the daily care of their soft contact lenses. Subjects were randomized to six possible sequences of use of each study solution: AMO Investigational MPS, Clear Care and OptiFree ReplenisH MPS.

Baseline Measures

	All Participants
Number of Participants [units: participants]	42
Age [units: participants]
<=18 years	1
Between 18 and 65 years	41
>=65 years	0
Age [units: years] Mean ± Standard Deviation	28.1 ± 10.9
Gender [units: participants]
Female	33
Male	9
Region of Enrollment [units: participants]
Canada	42

Outcome Measures

1. Primary:

Corneal Staining [ Time Frame: 4 weeks ]

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2. Secondary:

Subjective Lens Wearing Comfort [ Time Frame: 4 weeks ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

3. Secondary:

Dryness [ Time Frame: 4 weeks ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

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 NOT 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.

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: Clinical Scientist
Organization: Centre for Contact Lens Research
phone: 519-888-4567 ext 36590
e-mail: marc.schulze@uwaterloo.ca

No publications provided

Responsible Party:	Abbott Medical Optics
ClinicalTrials.gov Identifier:	NCT01294917 History of Changes
Other Study ID Numbers:	COBR-305-9608
Study First Received:	February 10, 2011
Results First Received:	February 15, 2012
Last Updated:	May 18, 2012
Health Authority:	Canada: Health Canada

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