Dispensing Evaluation of New Daily Disposable Toric Soft Contact Lens.

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ClinicalTrials.gov Identifier: NCT01055132

Recruitment Status : Completed

First Posted : January 25, 2010

Results First Posted : February 7, 2013

Last Update Posted : May 21, 2015

Sponsor:

Information provided by (Responsible Party):

Johnson & Johnson Vision Care, Inc.

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Single (Participant); Primary Purpose: Treatment
Condition:	Astigmatism
Interventions:	Device: Etafilcon A toric contact lens Device: Nelfilcon A toric 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
One subject failed screening, and did not enter group assignment

Reporting Groups

	Description
Etafilcon A Toric Lens First/ Nelfilcon A Toric Lens Second	Etafilcon A toric contact lens worn daily during first period of 5 - 9 days, then nelfilcon A toric contact lens worn daily during second period of 5 - 9 days
Nelfilcon A Toric Lens First/Etafilcon A Toric Lens Second	Nelfilcon A toric contact lens worn daily during first period of 5 - 9 days, then etafilcon A toric contact lens worn daily during second period of 5 - 9 days

Participant Flow for 2 periods

Period 1: Period 1 (5-9 Days)

	Etafilcon A Toric Lens First/ Nelfilcon A Toric Lens Second	Nelfilcon A Toric Lens First/Etafilcon A Toric Lens Second
STARTED	36	33
COMPLETED	35	33
NOT COMPLETED	1	0
unsatisfactory lens fitting performance	1	0

Period 2: Period 2 (5-9 Days)

	Etafilcon A Toric Lens First/ Nelfilcon A Toric Lens Second	Nelfilcon A Toric Lens First/Etafilcon A Toric Lens Second
STARTED	35	33
COMPLETED	35	32
NOT COMPLETED	0	1
Unsatisfactory lens fitting performance	0	1

Baseline Characteristics

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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.
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Reporting Groups

	Description
All Subjects	All subjects who completed the study.

Baseline Measures

	All Subjects
Overall Participants Analyzed [Units: Participants]	69

Age [Units: Years] Mean (Standard Deviation)	29.1 (5.27)

Gender [Units: Participants]
Female	45
Male	24

Region of Enrollment [Units: Participants]
United States	69

Outcome Measures

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1. Primary:

Monocular Visual Acuity on LogMAR Scale [ Time Frame: After 5 to 9 days of lens wear ]

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2. Primary:

Binocular Visual Acuity on LogMAR Scale [ Time Frame: After 5 to 9 days of lens wear ]

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3. Primary:

Subject Reported Overall Lens Comfort Using the Contact Lens User Evaluation (CLUE)TM Questionnaire [ Time Frame: After 5 to 9 days of lens wear ]

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4. Primary:

Subject Reported Overall Quality of Vision Using the Contact Lens User Evaluation(CLUE)TM Questionnaire. [ Time Frame: After 5 to 9 days of lens wear ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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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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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: Publications require agreement and written approval from Sponsor.

Results Point of Contact:

Name/Title: Ross Franklin
Organization: Johnson & Johnson Vision Care
phone: 1-904-443-1379
e-mail: RFrankl1@its.jnj.com

Responsible Party:	Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier:	NCT01055132 History of Changes
Other Study ID Numbers:	CR-1476AG
First Submitted:	January 22, 2010
First Posted:	January 25, 2010
Results First Submitted:	November 3, 2011
Results First Posted:	February 7, 2013
Last Update Posted:	May 21, 2015

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