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ClinicalTrials.gov Identifier: NCT01097863
Recruitment Status : Completed
First Posted : April 2, 2010
Results First Posted : June 27, 2011
Last Update Posted : July 10, 2012
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Myopia
Interventions: Device: nelfilcon A contact lens, modified inversion indicator
Device: nelfilcon A contact lens, no inversion indicator
Device: nelfilcon A contact lens, inversion indicator

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
This reporting group includes all enrolled and dispensed participants. Note: One subject was enrolled but not dispensed due to failing inclusion/exclusion criteria.

Reporting Groups
  Description
Nelfilcon A, Modified Inversion Indicator nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week
Nelfilcon A, No Inversion Indicator nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week
Nelfilcon A, Inversion Indicator nelfilcon A commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for one week.

Participant Flow:   Overall Study
    Nelfilcon A, Modified Inversion Indicator   Nelfilcon A, No Inversion Indicator   Nelfilcon A, Inversion Indicator
STARTED   90   98   91 
COMPLETED   89   98   89 
NOT COMPLETED   1   0   2 
Discomfort                1                0                1 
Did not return for final visit                0                0                1 



  Baseline Characteristics

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
Nelfilcon A, Modified Inversion Indicator nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week
Nelfilcon A, No Inversion Indicator nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week
Nelfilcon A, Inversion Indicator nelfilcon A commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for one week.
Total Total of all reporting groups

Baseline Measures
   Nelfilcon A, Modified Inversion Indicator   Nelfilcon A, No Inversion Indicator   Nelfilcon A, Inversion Indicator   Total 
Overall Participants Analyzed 
[Units: Participants]
 90   98   91   279 
Age 
[Units: Years]
Mean (Standard Deviation)
 36.2  (10.6)   33.3  (11.7)   34.1  (10.8)   34.5  (11.1) 
Gender 
[Units: Participants]
       
Female   52   69   69   190 
Male   38   29   22   89 


  Outcome Measures

1.  Primary:   Visibility of the Inversion Indicator on Lens When Lens Was on Participant's Finger, for Example, During Lens Insertion.   [ Time Frame: 1 week ]


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.


  More Information

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:
unchecked 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.
unchecked 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.


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



Responsible Party: Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier: NCT01097863     History of Changes
Other Study ID Numbers: P-346-C-010
First Submitted: March 31, 2010
First Posted: April 2, 2010
Results First Submitted: May 27, 2011
Results First Posted: June 27, 2011
Last Update Posted: July 10, 2012