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Comparative Study of Two Marketed 1-day Soft Contact Lenses

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Coopervision, Inc.
ClinicalTrials.gov Identifier:
NCT01464255
First received: October 26, 2011
Last updated: August 15, 2014
Last verified: August 2014
Results First Received: April 3, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single Blind (Subject)
Condition: Myopia
Interventions: Device: ocufilcon D
Device: ocufilcon 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
A total of 71 subjects were recruited for the study, with 21 subjects being disqualified at the initial screening for a total of 50 subjects started.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Fifty subjects started. Forty-nine subjects completed the study. One subject was disqualified after one week of wear of the control lens (ocufilcon B) during the 1st week of the study due to unresolved corneal staining.

Reporting Groups
  Description
Ocufilcon D Then Ocufilcon B Participants were randomized to wear ocufilcon D lenses for 1 week and then crossed over to the ocufilcon B lens pair for 1 week.
Ocufulcon B Then Ocufilcon D Participants were randomized to wear ocufilcon B lenses for 1 week and then crossed over to the ocufilcon D lens pair for 1 week.

Participant Flow:   Overall Study
    Ocufilcon D Then Ocufilcon B     Ocufulcon B Then Ocufilcon D  
STARTED     25     25  
COMPLETED     25     24  
NOT COMPLETED     0     1  
unresolve corneal staining                 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.
1 subject being disqualified after 1 week of wear

Reporting Groups
  Description
Ocufilcon D Then Ocufilcon B Participants were randomized to wear ocufilcon D lenses for 1 week and then crossed over to the ocufilcon B lens pair for 1 week.
Ocufilcon B Then Ocufilcon D Participants were randomized to wear ocufilcon B lenses for 1 week and then crossed over to the ocufilcon D lens pair for 1 week.
Total Total of all reporting groups

Baseline Measures
    Ocufilcon D Then Ocufilcon B     Ocufilcon B Then Ocufilcon D     Total  
Number of Participants  
[units: participants]
  25     24     49  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     25     24     49  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     17     15     32  
Male     8     9     17  
Region of Enrollment  
[units: participants]
     
United States     25     24     49  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Lens Fit – Decentration After Insertion   [ Time Frame: Baseline and 7 days from baseline visit ]

2.  Primary:   Lens Fit – Decentration at One Week   [ Time Frame: 7 days and 14 days from baseline visit ]

3.  Primary:   Lens Fit – Tightness After Insertion   [ Time Frame: Baseline and 7 days from baseline visit ]

4.  Primary:   Lens Fit – Tightness at One Week   [ Time Frame: 7 days and 14 days from baseline visit ]

5.  Primary:   Lens Fit – Post-Blink Lens Movement After Insertion   [ Time Frame: Baseline and 7 days from baseline visit ]

6.  Primary:   Lens Fit – Post-Blink Lens Movement Prior to Removal   [ Time Frame: 7 days and 14 days from baseline visit ]

7.  Secondary:   Overall Preference – Comfort After Insertion   [ Time Frame: 14 days from baseline visit ]

8.  Secondary:   Overall Preference – Comfort Before Removal   [ Time Frame: 14 days from baseline visit ]

9.  Secondary:   Overall Preference – Dryness After Insertion   [ Time Frame: 14 days from baseline visit ]

10.  Secondary:   Overall Preference – Dryness Before Removal   [ Time Frame: 14 days from baseline visit ]

11.  Secondary:   Overall Preference – Handling, Inserting   [ Time Frame: 14 days from baseline visit ]

12.  Secondary:   Overall Preference – Handling, Removing   [ Time Frame: 14 days from baseline visit ]

13.  Secondary:   Overall Lens Pair Preference   [ Time Frame: 14 days from baseline visit ]


  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
No text entered.


  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:
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: Thao N Yeh, O.D.
Organization: Clinical Research Center, University of California, Berkeley, School of Optometry
phone: (510) 642-9649
e-mail: thaoyeh@berkeley.edu


No publications provided


Responsible Party: Coopervision, Inc.
ClinicalTrials.gov Identifier: NCT01464255     History of Changes
Other Study ID Numbers: CV-OMC-01
Study First Received: October 26, 2011
Results First Received: April 3, 2014
Last Updated: August 15, 2014
Health Authority: United States: Institutional Review Board