The Clinical Evaluation of Two Daily Disposable Contact Lenses

This study has been completed.

Sponsor:

Collaborator:

Eurolens Research

Information provided by (Responsible Party):

Vistakon

ClinicalTrials.gov Identifier:

NCT00762996

First received: September 26, 2008

Last updated: November 14, 2011

Last verified: November 2011

History of Changes

Results First Received: October 24, 2008

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Single Blind (Subject); Primary Purpose: Treatment
Condition:	Myopia
Interventions:	Device: etafilcon A Device: omafilcon A

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
No text entered.

Reporting Groups

	Description
Etafilcon A / Etafilcon A	Period 1: etafilcon A, Period 2: etafilcon A
Etafilcon A / Omafilcon A	Period 1: etafilcon A, Period 2: omafilcon A
Omafilcon A / Etafilcon A	Period 1: omafilcon A, Period 2: etafilcon A
Omafilcon A / Omafilcon A	Period 1: omafilcon A, Period 2: omafilcon A

Participant Flow for 2 periods

Period 1: Period One

	Etafilcon A / Etafilcon A	Etafilcon A / Omafilcon A	Omafilcon A / Etafilcon A	Omafilcon A / Omafilcon A
STARTED	15	16	17	17
COMPLETED	15	16	13	16
NOT COMPLETED	0	0	4	1
Protocol Violation	0	0	1	0
ineligible	0	0	1	1
Adverse Event	0	0	1	0
Withdrawal by Subject	0	0	1	0

Period 2: Period Two

	Etafilcon A / Etafilcon A	Etafilcon A / Omafilcon A	Omafilcon A / Etafilcon A	Omafilcon A / Omafilcon A
STARTED	15	16	13	16
COMPLETED	15	16	13	16
NOT COMPLETED	0	0	0	0

Baseline Characteristics

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Reporting Groups

	Description
Entire Population	No text entered.

Baseline Measures

	Entire Population
Number of Participants [units: participants]	65
Age [units: years] Mean ± Standard Deviation	28.9 ± 5.3
Gender [units: participants]
Female	41
Male	24

Outcome Measures

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1. Primary:

Distance Visual Acuity [ Time Frame: 1 week ]

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2. Secondary:

Lens Comfort [ Time Frame: 1 week ]

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Measure Type	Secondary
Measure Title	Lens Comfort
Measure Description	A weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale: 1=most negative response to 5=most positive was used to derive comfort outcomes. The analysis shows the difference in outcome between the test and control.>0 = comfortable, <0 = uncomfortable
Time Frame	1 week
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
Etafilcon A	No text entered.
Omafilcon A	No text entered.

Measured Values

	Etafilcon A	Omafilcon A
Number of Participants Analyzed [units: participants]	15	16
Lens Comfort [units: Units on a scale] Least Squares Mean ± Standard Error	0.3113 ± 0.1765	-0.1645 ± 0.2075

Statistical Analysis 1 for Lens Comfort

Groups ^[1]	All groups
Mean Difference (Final Values) ^[2]	0.4757
Standard Error of the mean	± 0.2505
95% Confidence Interval	( 0.05563 to 0.4757 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant estimation information:
	Mean difference is etafilcon A minus omafilcon A.

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: The PI may not publish, divulge, reveal, disclose, or use the data and or results of the study without prior written consent of Vistakon.

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: Kurt Moody, OD, FAAO
Organization: Vistakon
phone: 904-443-3088

No publications provided

Responsible Party:	Vistakon
ClinicalTrials.gov Identifier:	NCT00762996 History of Changes
Other Study ID Numbers:	CR-0707
Study First Received:	September 26, 2008
Results First Received:	October 24, 2008
Last Updated:	November 14, 2011
Health Authority:	United Kingdom: Research Ethics Committee

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