Trial record 1 of 1 for: NCT00975585

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Clinical Performance Comparison of Two Contact Lenses

This study has been completed.

Sponsor:

Collaborator:

Visioncare Research Ltd.

Information provided by (Responsible Party):

Vistakon

ClinicalTrials.gov Identifier:

NCT00975585

First received: September 10, 2009

Last updated: October 6, 2011

Last verified: October 2011

History of Changes

Results First Received: February 18, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single Blind (Subject); Primary Purpose: Treatment
Condition:	Myopia
Interventions:	Device: senofilcon A Device: lotrafilcon B

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
Senofilcon A	contact lens
Lotrafilcon B	contact lens

Participant Flow: Overall Study

	Senofilcon A	Lotrafilcon B
STARTED	184	195
COMPLETED	177	183
NOT COMPLETED	7	12
Adverse Event	0	4
Lost to Follow-up	3	5
Withdrawal by Subject	2	1
Lens issue	2	2

Baseline Characteristics

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Reporting Groups

	Description
Senofilcon A	contact lens
Lotrafilcon B	contact lens
Total	Total of all reporting groups

Baseline Measures

	Senofilcon A	Lotrafilcon B	Total
Number of Participants [units: participants]	184	195	379
Age [units: years] Mean ± Standard Deviation	29.7 ± 7.0	29.3 ± 6.9	29.5 ± 6.9
Gender [units: participants]
Female	125	136	261
Male	59	59	118
Region of Enrollment [units: participants]
United States	184	195	379

Outcome Measures

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1. Primary:

Average Corneal Staining [ Time Frame: 2 weeks ]

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2. Primary:

Visual Acuity [ Time Frame: 2 weeks ]

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3. Primary:

Overall Comfort [ Time Frame: 2 weeks ]

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4. Primary:

Overall Comfort [ Time Frame: 2 weeks and 4 weeks ]

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5. Secondary:

Limbal Redness [ Time Frame: 2 weeks ]

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6. Secondary:

Bulbar Redness [ Time Frame: 2 weeks ]

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7. Secondary:

Symptoms of Dryness [ Time Frame: 2 weeks ]

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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: Prior to submission for publication or presentation, the PI will provide SPONSOR with at least sixty (60) days for review of a manuscript. Notwithstanding the foregoing, no paper that incorporates SPONSOR Confidential Information will be submitted for publication without SPONSOR’s prior written consent. If requested in writing, the PI will withhold such publication for up to an additional sixty (60) days to allow for filing of a patent application.

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: Sheila Hickson-Curran, MCOptom/ Director, Medical Affairs
Organization: Vistakon
phone: 904-443-1754

No publications provided

Responsible Party:	Vistakon
ClinicalTrials.gov Identifier:	NCT00975585 History of Changes
Other Study ID Numbers:	CR-0907, PHNX-518
Study First Received:	September 10, 2009
Results First Received:	February 18, 2011
Last Updated:	October 6, 2011
Health Authority:	United States: Institutional Review Board

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