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Multi-Centre Clinical Evaluation Of Two Daily Disposable Contact Lenses

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Coopervision, Inc.
ClinicalTrials.gov Identifier:
NCT01707238
First received: September 21, 2012
Last updated: August 25, 2014
Last verified: August 2014
Results First Received: April 1, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator)
Condition: Myopia
Interventions: Device: etafilcon A
Device: stenfilcon 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
Number subjects enrolled per site ranged six to 25. Two sites were asked to enroll more than 20 subjects to fulfill required number of subjects. Approval from Ethics Committee sought before sites were invited to recruit additional subjects. Of the 100 enrolled, 13 were existing etafilcon A wearers, falling short of the 25% target.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All participants randomized to receive all interventions and combined into one Arm/Group, “Overall All Study Population” for the participant flow.

Reporting Groups
  Description
Stenfilcon A Then Etafilcon A All subjects assigned as overall study population wore both sets of lenses. Overall study population was randomized to wear either stenfilcon A followed by etafilcon A or etafilcon A followed by stenfilcon A.
Etafilcon A Then Stenfilcon A All subjects assigned as overall study population wore both sets of lenses. Study population was randomized to wear either stenfilcon A followed by etafilcon A or etafilcon A followed by stenfilcon A.

Participant Flow:   Overall Study
    Stenfilcon A Then Etafilcon A     Etafilcon A Then Stenfilcon A  
STARTED     48     52  
COMPLETED     48     52  
NOT COMPLETED     0     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.
All subjects assigned as overall study population wore both sets of lenses. Study population was randomized to wear either stenfilcon A followed by etafilcon A or etafilcon A followed by stenfilcon A.

Reporting Groups
  Description
Stenfilcon A Then Etafilcon A All subjects assigned as overall study population wore both sets of lenses. Overall study population was randomized to wear either stenfilcon A followed by etafilcon A or etafilcon A followed by stenfilcon A.
Etafilcon A Then Stenfilcon A All subjects assigned as overall study population wore both sets of lenses. Overall study population was randomized to wear either stenfilcon A followed by etafilcon A or etafilcon A followed by stenfilcon A.
Total Total of all reporting groups

Baseline Measures
    Stenfilcon A Then Etafilcon A     Etafilcon A Then Stenfilcon A     Total  
Number of Participants  
[units: participants]
  48     52     100  
Age  
[units: participants]
     
<=18 years     6     11     17  
Between 18 and 65 years     42     41     83  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     31     38     69  
Male     17     14     31  
Region of Enrollment  
[units: participants]
     
United Kingdom     48     52     100  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Handling   [ Time Frame: two weeks and four weeks from baseline visit ]

2.  Primary:   Satisfaction With Handling   [ Time Frame: two weeks and four weeks from baseline visit ]

3.  Secondary:   Comfort   [ Time Frame: two weeks and four weeks from baseline visit ]

4.  Secondary:   Dryness   [ Time Frame: two weeks and four weeks from baseline visit ]

5.  Secondary:   Satisfaction With Dryness   [ Time Frame: two weeks and four weeks from baseline visit ]

6.  Secondary:   Satisfaction With Comfort   [ Time Frame: two weeks and four weeks 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
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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:
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: Graeme Young
Organization: Visioncare Research Ltd.
phone: 01252 718719 ext 207
e-mail: g.young@visioncare.co.uk


No publications provided


Responsible Party: Coopervision, Inc.
ClinicalTrials.gov Identifier: NCT01707238     History of Changes
Other Study ID Numbers: EX-MKTG-39
Study First Received: September 21, 2012
Results First Received: April 1, 2014
Last Updated: August 25, 2014
Health Authority: United Kingdom: Research Ethics Committee