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Daily Disposable Contact Lens Tear Film Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01473160
First Posted: November 17, 2011
Last Update Posted: April 17, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Aston University
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
Results First Submitted: November 19, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition: Myopia
Interventions: Device: delefilcon A contact lens
Device: narafilcon A 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
Participants were recruited from one study center in the UK.

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
Overall Study All enrolled participants

Participant Flow:   Overall Study
    Overall Study
STARTED   9 
COMPLETED   9 
NOT COMPLETED   0 



  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.
No text entered.

Reporting Groups
  Description
Overall Study All enrolled participants

Baseline Measures
   Overall Study 
Overall Participants Analyzed 
[Units: Participants]
 9 
Age 
[Units: Years]
Mean (Standard Deviation)
 31  (7) 
Gender 
[Units: Participants]
 
Female   4 
Male   5 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Corrected Visual Acuity of 0.0 or Better   [ Time Frame: Up to 16 hours after lens insertion ]

2.  Primary:   Pre-Lens Noninvasive Tear Break-Up Time   [ Time Frame: Up to 16 hours after lens insertion ]

3.  Primary:   Average Tear Meniscus Height   [ Time Frame: Up to 16 hours after lens insertion ]

4.  Primary:   Average Ocular Surface Temperature   [ Time Frame: Up to 16 hours after lens insertion ]

5.  Secondary:   Subjective Comfort   [ Time Frame: Up to 16 hours after lens insertion ]

6.  Secondary:   Subjective Vision   [ Time Frame: Up to 16 hours after lens insertion ]

7.  Secondary:   Number of Participants With Adequate Lens Fit   [ Time Frame: Up to 16 hours after lens insertion ]


  Serious Adverse Events


  Other Adverse Events


  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
Pilot study. Small number of participants analyzed.


  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.


Results Point of Contact:  
Name/Title: Joachim Nick, Dipl. Ing.
Organization: Alcon Research, Ltd.
phone: +49 6022 240 520
e-mail: joachim.nick@cibavision.com



Responsible Party: Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier: NCT01473160     History of Changes
Other Study ID Numbers: P-347-C-014v2
First Submitted: November 14, 2011
First Posted: November 17, 2011
Results First Submitted: November 19, 2012
Results First Posted: January 16, 2013
Last Update Posted: April 17, 2013